{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SANTA CLARA", "manufacturer_contact_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_contact_pcity": "40852321", "event_type": "Injury", "report_number": "2955842-2022-10959", "type_of_report": [ "Initial submission", "Followup", "Followup", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20220408", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20210714", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Study", "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20220409", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20180928", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1186877", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220408", "brand_name": "DA VINCI SP", "generic_name": "PATIENT SIDE CART", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_d_address_2": "", "manufacturer_d_city": "SANTA CLARA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "380601-33", "catalog_number": "380601", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "00886874114605", "udi_public": "(01)00886874114605", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "MN", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/10/2022;06/06/2022;03/01/2023;03/08/2024", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250819", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "4085", "patient": [ { "patient_sequence_number": "1", "date_received": "20220408", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "82 YR", "patient_sex": "Male", "patient_weight": "73 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "White", "patient_problems": [ "Dehydration", "Purulent Discharge", "Fever", "Electrolyte Imbalance", "Dehydration", "Purulent Discharge", "Fever", "Electrolyte Imbalance" ] } ], "distributor_city": "", "date_report": "20210916", "initial_report_to_fda": "Yes", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "14063343", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220407", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "INTUITIVE SURGICAL, INC", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "294607789", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "SP COLORECTAL PROCEDURES: LEAK RATES FROM COLORECTAL ANASTOMOSIS VARY BETWEEN 6 TO 30% BASED ON DIFFERENT RISK FACTORS AND VARYING DEFINITIONS OF ANASTOMOTIC LEAK. 1 FAILURE OF COLORECTAL ANASTOMOSIS CAN LEAD TO DIRE CONSEQUENCES SUCH AS PROLONGED HOSPITALIZATIONS, ADDITIONAL INTERVENTIONS, AND INCREASED MORBIDITY AND MORTALITY. 2 THE MOST CONSISTENT DETERMINANT OF A COLORECTAL ANASTOMOTIC LEAK IS THE ANASTOMOTIC LOCATION. INITIALLY, THE CONNECTION OF THE COLORECTAL ANASTOMOSIS MUST BE MAINTAINED BY THE CHOSEN SURGICAL TECHNIQUE BECAUSE NO STRENGTH COMES FROM TISSUE HEALING. REGARDLESS OF THE CHOSEN TECHNIQUE, THE PRINCIPLES OF A PROPER ANASTOMOSIS, A TENSION-FREE APPROXIMATION OF HEALTHY, WELL-PERFUSED UNOBSTRUCTED BOWEL, NEED TO BE FOLLOWED TO MINIMIZE THE POTENTIAL FOR A LEAK. THE MORE DISTAL THE ANASTOMOSIS, THE HIGHER THE LIKELIHOOD OF FAILURE, WITH RESECTION OF A DISTAL RECTAL CANCER HAVING ALMOST A FIVE-FOLD INCREASED RISK OF ANASTOMOTIC LEAK COMPARTED WITH RESECTION FOR COLON CANCER. 3 COLORECTAL ANASTOMOSIS LOCATED WITHIN 6 CM OF THE ANAL VERGE ARE VERY LIKELY TO LEAK. DIVERTING ILEOSTOMIES ARE TYPICALLY CREATED TO PROTECT THE DISTAL COLORECTAL ANASTOMOSIS TO DECREASE THE RISK OF ANASTOMOTIC LEAK AND THE NEED FOR AN URGENT REOPERATION. 4 ILEOSTOMIES ARE TECHNICALLY RATHER EASY TO CREATE AND ARE INTENDED TO BE REVERSED AFTER THE COLORECTAL ANASTOMOSIS HAS HEALED (TYPICALLY 3 TO 6 MONTHS AFTER THE PRIMARY PROCEDURE). HOWEVER, DIVERTING ILEOSTOMIES CAN BE ASSOCIATED WITH POSTOPERATIVE MORBIDITY THAT CAN REDUCE THE PATIENT¿S QUALITY OF LIFE DURING RECOVERY. DEHYDRATION AND STOMA COMPLICATIONS ARE COMMON. 5 CLOSURE OF A LOOP ILEOSTOMY IS A RELATIVELY SIMPLE PROCEDURE. POSTOPERATIVE COMPLICATIONS SUCH AS BOWEL OBSTRUCTION, WOUND INFECTION, PERITONITIS DUE TO ANASTOMOTIC LEAK FROM THE CLOSURE OF THE LOOP ILEOSTOMY, INTRA-ABDOMINAL ABSCESS, ANASTOMOTIC LEAK FROM THE CLOSURE OF THE LOOP ILEOSTOMY WITH ENTEROCUTANEOUS FISTULA, AND BLEEDING CAN OCCUR. 6 THE MOST COMMON COMPLICATION OF THE LOOP ILEOSTOMY CLOSURE IS BOWEL OBSTRUCTION. REFERENCES: PEEL AL, TAYLOR EW; SURGICAL INFECTION STUDY GROUP. PROPOSED DEFINITIONS FOR THE AUDIT OF POSTOPERATIVE INFECTION: A DISCUSSION PAPER. ANN R COLLSURGENGL 1991;73(6):385¿388 NT. DIETZ UA, DEBUS ES. INTESTINAL ANASTOMOSES PRIOR TO 1882; A LEGACY OF INGENUITY, PERSISTENCE, AND RESEARCH FORM A FOUNDATION FOR MODERN GASTROINTESTINAL SURGERY. WORLD J SURG 2005;29(3):396¿401. MIRNEZAMI A, MIRNEZAMI R, CHANDRAKUMARAN K, SASAPU K, SAGAR P, FINAN P. INCREASED LOCAL RECURRENCE AND REDUCED SURVIVAL FROM COLORECTAL CANCER FOLLOWING ANASTOMOTIC LEAK: SYSTEMATIC REVIEW AND META-ANALYSIS. ANN SURG 2011;253(5):890¿899 HANNA MH, VINCI A, PIGAZZI A. DIVERTING ILEOSTOMY IN COLORECTAL SURGERY: WHEN IS IT NECESSARY? LANGENBECKS ARCH SURG. 2015 FEB;400(2):145-52. DOI: 10.1007/S00423-015-1275-1. EPUB 2015 JAN 30. PMID: 25633276. NHS, HTTPS://WWW.NHS.UK/CONDITIONS/ILEOSTOMY/RISKS. POSKUS E, KILDUSIS E, SMOLSKAS E, AMBRAZEVICIUS M, STRUPAS K: COMPLICATIONS AFTER LOOP ILEOSTOMY CLOSURE: A RETROSPECTIVE ANALYSIS OF 132 PATIENTS. VISZERALMEDIZIN 2014;30:276-280. DOI: 10.1159/000366218. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION PROCEDURE, THE PATIENT DEVELOPED POST-OPERATIVE COMPLICATIONS WHICH REQUIRED MEDICAL INTERVENTION. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. THE CAUSE OF THE POST-OPERATIVE COMPLICATIONS IS UNKNOWN. THE INJURY WAS INITIALLY REPORTED TO THE FDA IN THE IDE ANNUAL PROGRESS REPORT (B)(4)." }, { "mdr_text_key": "294607790", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ON (B)(6) 2021, THE SUBJECT (B)(6) UNDERWENT ROBOTIC-ASSISTED LOWER ANTERIOR RESECTION WITH HANDSEWN COLO-ANAL ANASTOMOSIS USING THE DA VINCI SP SURGICAL SYSTEM WITH DIVERTING LOOP ILEOSTOMY. AFTER DOCKING THE SP ROBOT, A SECONDARY PORT FOR THE STAPLING DEVICE WAS UTILIZED IN THE RIGHT LOWER QUADRANT. IT WAS NOTED THAT THE PROCEDURE WAS SUBSTANTIALLY MORE DIFFICULT BECAUSE OF SIGNIFICANT DIFFICULTY WITH MOBILIZING AND IDENTIFYING ANATOMICAL STRUCTURES DUE TO THE ALTERED SURGICAL FIELD SECONDARY TO INFLAMMATION AND TISSUE FRIABILITY LIKELY DUE TO HIS PREVIOUS HEMATOLOGICAL MALIGNANCY AND CURRENT THERAPY. THE TUMOR WAS LOCATED WITHIN A FINGER BREADTH OF THE ANAL CANAL AND DISSECTION AROUND THIS TUMOR NECESSITATED HANDSEWN COLO-ANAL ANASTOMOSIS WHICH WAS DONE WITH A STANDARD MUCOSECTOMY. THE SPECIMEN WAS DELIVERED THROUGH THE ANAL CANAL AND THEN SEWN TO THE DESCENDING COLON WITH VICRYL SUTURES. THE ANASTOMOSIS WAS EVALUATED AND FOUND TO BE VIABLE. A SINGLE DRAIN WAS LEFT IN THE DEEP PELVIS. THE TERMINAL ILEUM WAS IDENTIFIED AND BROUGHT OUT OF THE ILEOSTOMY SITE. CLOSURE OF THE SITE WAS COMPLETED. THE SUBJECT DID NOT EXPERIENCE ANY INTRAOPERATIVE COMPLICATIONS, AND THERE WAS NO CONVERSION TO OPEN SURGERY, ROBOTIC MULTIPORT OR LAPAROSCOPIC PROCEDURES. THE SUBJECT HAD NO POSTOPERATIVE COMPLICATIONS AND RESUMED A REGULAR DIET ON POD 1 ((B)(6) 2021). THE DRAIN WAS REMOVED, AND SUBJECT WAS DISCHARGED TO HOME ON POD 4 ((B)(6) 2021). DURING THE 14-DAY FOLLOW UP ON (B)(6) 2021, THE SUBJECT WAS NOTED TO HAVE NO ADVERSE EVENTS (AES) DURING THE FOLLOW UP PERIOD. THE SUBJECT PRESENTED TO THE ED ON (B)(6) 2021 FOR EVALUATION DUE TO HIGH ILEOSTOMY OUTPUT, GENERALIZED WEAKNESS, AND SIGNS OF DEHYDRATION. THE SUBJECT WAS DIAGNOSED WITH DEHYDRATION SECONDARY TO HIGH ILEOSTOMY OUTPUT AND TREATED WITH IV FLUIDS, FOLLOWING WHICH HIS CONDITION IMPROVED. HE WAS STARTED ON METAMUCIL AND IMODIUM. HE WAS HOSPITALIZED FROM (B)(6) 2021 AND DISCHARGED WITH A PLAN TO CONTROL HIS OSTOMY OUTPUT (METAMUCIL, IMODIUM, OMEPRAZOLE AND STOOL THICKENING DIET). THE ADVERSE EVENT OF DEHYDRATION WAS CONSIDERED TO BE RESOLVED AT DISCHARGE. DURING AN OUTPATIENT VISIT ON (B)(6) 2021 FOR THE CLOSURE OF ILEOSTOMY, IT WAS NOTED THAT THE SUBJECT HAD A POSTERIOR SINUS WHICH HAD LIKELY RESULTED FROM A LEAK AT THE POSTERIOR ANASTOMOSIS WITH DRAINAGE INTO THE PRESACRAL SPACE. THE SUBJECT WAS WILLING TO WAIT FOR A PERIOD OF 3 MONTHS FOR TAKE DOWN AT THAT TIME. THE SUBJECT WAS SEEN IN THE ED ON (B)(6) 2021 WITH COMPLAINTS OF FEVER, INCREASING ABDOMINAL PAIN AND PURULENT RECTAL DISCHARGE. THE CT SCAN DID NOT DEMONSTRATE AN ABSCESS AND THE SUBJECT WAS NOT ADMITTED DURING THIS VISIT. DURING A FOLLOW UP ON (B)(6) 2021, A FLEXIBLE SIGMOIDOSCOPY WAS PLANNED TO EVALUATE THE COLON AND RECTUM. THIS PROCEDURE WAS PERFORMED ON (B)(6) 2021 WHICH DEMONSTRATED AN ANASTOMOTIC STRICTURE. THE SINUS TRACT WAS FREELY DRAINING, AND IT WAS NOTED THAT THE SUBJECT WOULD NOT BENEFIT FROM SUTURING AT THIS POINT. THE RECOMMENDATION WAS FOR EXAMINATION UNDER ANESTHESIA WITH ANAL DILATATION AND EVALUATION OF THE SINUS TRACT TO BE PERFORMED IF THE SUBJECT¿S SYMPTOMS WORSENED, AND THIS WAS DONE ON (B)(6) 2021. THE PROCEDURE REVEALED A VERY NARROW ANASTOMOSIS THAT WAS LIKELY DUE TO SOME HEALING AT THIS AREA. THE AREA WAS DILATED, AND THE POSTERIOR SINUS TRACT WAS INFILTRATED WITH FIBRIN GLUE. THE STUDY INVESTIGATOR CLASSIFIED THE PRIMARY AE OF HIGH STOMA OUTPUT WITH ONSET ON (B)(6) 2021 AND RESOLUTION ON (B)(6) 2021, AS POSSIBLY RELATED TO THE UNDERLYING DISEASE AND NOT RELATED TO THE LAR PROCEDURE OR THE STUDY DEVICE. THE STUDY INVESTIGATOR CLASSIFIED THE AE OF DEHYDRATION SECONDARY TO HIGH ILEOSTOMY OUTPUT AS AN SAE WITH ONSET ON (B)(6) 2021 AND RESOLUTION ON (B)(6) 2021 AS POSSIBLY RELATED TO THE UNDERLYING DISEASE AND NOT RELATED TO THE LAR PROCEDURE OR THE STUDY DEVICE. THE STUDY INVESTIGATOR CLASSIFIED THE PRIMARY AE OF ANASTOMOTIC LEAKAGE AS AN ONGOING AE AT THE TIME OF THE ANNUAL PROGRESS REPORT ((B)(6) 2022), WITH ONSET ON (B)(6) 2021, AS POSSIBLY RELATED TO THE PROCEDURE AND THE UNDERLYING DISEASE AND NOT RELATED TO THE STUDY DEVICE." }, { "mdr_text_key": "329439228", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING SECTIONS: G6, H2, AND H10/H11. CORRECTED DATA CAN BE FOUND IN SECTION H10/H11. ON 10-APR-2022, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING CORRECTED INFORMATION FROM THE INDEPENDENT DATA SAFETY MONITOR (DSM): THE DEHYDRATION SECONDARY TO HIGH ILEOSTOMY OUTPUT WAS AN ANTICIPATED SERIOUS ADVERSE EVENT (SAE)." }, { "mdr_text_key": "329439229", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "329812998", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ON 6-JUNE-2022, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION ABOUT THE REPORTED EVENT: PROCEDURE INDICATION WAS FOR MALIGNANT TUMOR (ADENOCARCINOMA), THE SUBJECT HAD AN EXTRACORPOREAL APPROACH ANASTOMOSIS, END TO END VIA HAND-SEWN, THE SUBJECT HAD A DIVERTING ILEOSTOMY WHICH WAS PLANNED AND DUE TO THE PERIOPERATIVE TREATMENT AND HEIGHT OF ANASTOMOSIS. THE INVESTIGATOR STATED THAT THE REASON FOR A LAR IS THAT THIS WOULD BE STANDARD OF CARE FOR ANY PATIENT WITH GREATER THAN 1-2 MM OF DISTAL MARGIN AND THE ABILITY TO PRESERVE THE MAJORITY OF THE ANAL SPHINCTER. PER THE INVESTIGATOR, THE SUBJECT¿S DEHYDRATION WAS SECONDARY TO HIGH ILEOSTOMY (STOMA) OUTPUT AND THEREFORE WAS ORIGINALLY REPORTED AS A SEQUELA TO THE PRIMARY ADVERSE EVENT OF HIGH STOMA OUTPUT. PREVIOUSLY, DEHYDRATION WAS NOTED AS A SEQUELA ADVERSE EVENT. THE INVESTIGATOR CLARIFIED THAT DEHYDRATION AND HIGH STOMA OUTPUT SHOULD BOTH BE REPORTED AS SAES. IN ADDITION, GENERALIZED MUSCLE WEAKNESS HAS BEEN REPORTED AS SEPARATE AE. THE INVESTIGATOR HAS CLARIFIED THAT THE ANASTOMOTIC STRICTURE IS THE NORMAL PROGRESSION FOR A DEFUNCTIONED ANASTOMOSIS, IT IS ALSO THE NORMAL FINDING FOR SOMEONE WITH AN ASSOCIATED LEAK. BASED ON THE INVESTIGATOR¿S EXPLANATION, THE ANASTOMOTIC STRICTURE IS LIKELY TO OCCUR DUE TO THE ANASTOMOSIS AND THE LEAK, NOT RELATED TO THE USE OF THE STUDY DEVICE. ANASTOMOTIC LEAK OR STRICTURE CAN BE A FUNCTION OF BLOOD FLOW CHANGE, WHICH COULD HAPPEN FOR ANY LAR PROCEDURE, REGARDLESS OF THE SURGICAL APPROACH AND TOOL USED FOR THE OPERATION. THE INVESTIGATOR INDICATED THAT ANASTOMOTIC STRICTURE SHOULD BE REPORTED AS AN AE. THE INVESTIGATOR STATED THAT THE ANASTOMOSIS WAS PERFORMED WITH AN END-TO-END HAND-SEWN TECHNIQUE AND WAS NOT CREATED WITH THE SP DEVICE. THUS, THE INVESTIGATOR DEEMED THAT THE ANASTOMOTIC COMPLICATION WAS NOT RELATED TO THE SP DEVICE. THE STUDY INVESTIGATOR CLASSIFIED THE PRIMARY SAE OF HIGH STOMA OUTPUT WITH ONSET ON (B)(6) 2021 AND RESOLUTION ON (B)(6) 2021, AS NOT RELATED TO THE SP SURGICAL SYSTEM, POSSIBLY RELATED TO THE UNDERLYING DISEASE, AND POSSIBLY RELATED TO THE LAR PROCEDURE. THE STUDY INVESTIGATOR CLASSIFIED THE AE OF DEHYDRATION SECONDARY TO HIGH ILEOSTOMY OUTPUT AS AN SAE WITH ONSET ON (B)(6) 2021 AND RESOLUTION ON (B)(6) 2021 AS NOT RELATED TO THE SP SURGICAL SYSTEM AND POSSIBLY RELATED TO THE UNDERLYING DISEASE AND TO THE LAR PROCEDURE. THE STUDY INVESTIGATOR CLASSIFIED THE AE OF GENERALIZED MUSCLE WEAKNESS SECONDARY TO HIGH ILEOSTOMY OUTPUT AS AN AE WITH ONSET ON (B)(6) 2021 AND RESOLUTION ON (B)(6) 2021 AS NOT RELATED TO THE SP SURGICAL SYSTEM AND POSSIBLY RELATED TO THE UNDERLYING DISEASE AND TO THE LAR PROCEDURE. THE STUDY INVESTIGATOR CLASSIFIED THE PRIMARY AE OF THE ANASTOMOTIC STRICTURE WITH ONSET ON (B)(6) 2021 AND RESOLUTION ON (B)(6) 2022 AS NOT RELATED TO THE SP SURGICAL SYSTEM, AND POSSIBLY RELATED TO THE UNDERLYING DISEASE AND TO THE LAR PROCEDURE." }, { "mdr_text_key": "329812999", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "334175650", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ON (B)(6) 2021, THE SUBJECT 600-03 UNDERWENT ROBOTIC-ASSISTED LOWER ANTERIOR RESECTION WITH HANDSEWN COLO-ANAL ANASTOMOSIS USING THE DA VINCI SP SURGICAL SYSTEM WITH DIVERTING LOOP ILEOSTOMY AS PART OF THE CLINICAL STUDY. APPROXIMATE 2 WEEKS LATER, THE PATIENT WAS SEEN AT THE EMERGENCY ROOM (ER) ON (B)(6) 2021 FOR ABNORMAL SODIUM LEVELS, WITH NO SYMPTOMS MENTIONED. THE PATIENT WAS GIVEN IV FLUIDS AND WAS DISCHARGED THE SAME DAY. THERE WAS NO ALLEGATION OF MALFUNCTIONS OF INSTRUMENTS, SYSTEMS OR ACCESSORIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE WERE NO ER NOTES REGARDING THE ER VISIT ON (B)(6) 2021, BUT IT WAS MENTIONED IN THE SUBSEQUENT ER VISIT ON (B)(6) 2021 FOR DEHYDRATION SECONDARY TO THE HIGH ILEOSTOMY OUTPUT AS REPORTED IN MANUFACTURER REPORT NUMBER 2955842-2022-10959." }, { "mdr_text_key": "334175651", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "340258565", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "340258566", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE PATIENT MADE AN INFORMED DECISION TO PROCEED WITH PERMANENT COLOSTOMY INSTEAD OF ILEOSTOMY TAKE DOWN IN CONSIDERATION OF THE FUNCTIONAL CONSEQUENCES OF AN ANASTOMOSIS AND THE RISKS ASSOCIATED WITH ANASTOMOTIC LEAKAGE. ON (B)(6) 2022, THE PATIENT HAD A ROBOTIC ASSISTED ABDOMINAL PERIANAL RESECTION, LAPAROSCOPIC COLOSTOMY CONSTRUCTION AND CLOSURE OF ILEOSTOMY. HE WAS DISCHARGED TO HOME ON (B)(6) 2022 AFTER CONFIRMATION OF APPROPRIATE BOWEL FUNCTION AND RESUMPTION OF REGULAR DIET." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "05/09/2022;06/13/2022;03/23/2023;04/03/2024" } ] }