{ "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": "2955842-2022-10960", "type_of_report": [ "Initial submission", "Followup", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20220408", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20210827", "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": [ "Other", "Study", "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", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1281909", "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", "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": "", "udi_public": "", "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": "TX", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/06/2022;08/10/2022;09/12/2022", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250731", "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": "76 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "White", "patient_problems": [ "Failure to Anastomose", "Hematoma", "Pain", "Failure to Anastomose", "Hematoma", "Pain" ] } ], "distributor_city": "", "date_report": "20210831", "initial_report_to_fda": "Yes", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "14063383", "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": "294644357", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "(B)(6) (HEREAFTER REFERRED TO AS THE SUBJECT) IS A 76-YEAR-OLD WHITE MALE WITH BMI 27.35 AND ASA CLASSIFICATION III, NON-SMOKER WITH A MEDICAL HISTORY OF CHRONIC KIDNEY DISEASE (STAGE 3), ESSENTIAL HYPERTENSION (ON TREATMENT WITH AMLODIPINE AND CARVEDILOL), RHEUMATOID ARTHRITIS, ATRIAL FIBRILLATION, ARRYTHMIA (ON ELIQUIS, STOPPED THREE DAYS PRIOR TO THE LAR PROCEDURE), DIABETES MELLITUS, MYOCARDIAL INFARCTION (1968), SLEEP APNEA AND COMPLETE HEARING LOSS IN THE LEFT EAR. HE ALSO HAS A SURGICAL HISTORY OF RIGHT KNEE JOINT REPLACEMENT IN 2013 AND ROTATOR CUFF REPAIR IN 2018. HE HAS BEEN VACCINATED FOR COVID-19 IN (B)(6) 2021. THE SUBJECT HAD A HISTORY OF DIARRHEA OVER SEVERAL MONTHS LEADING TO HOSPITALIZATION WITH HYPOTENSION AND DEHYDRATION. HE WAS SUBSEQUENTLY DIAGNOSED WITH A RECTAL MASS ON FLEXIBLE SIGMOIDOSCOPY PERFORMED ON (B)(6) 2021. ON (B)(6) 2021, THE SUBJECT MET ALL STUDY ELIGIBILITY CRITERIA AND SIGNED THE INFORMED CONSENT. ON (B)(6) 2021, THE SUBJECT UNDERWENT ROBOT-ASSISTED LOW ANTERIOR COLON RESECTION AND PRIMARY COLORECTAL ANASTOMOSIS PROCEDURE USING THE DA VINCI SP SURGICAL SYSTEM. AFTER GAINING ACCESS AND INTRODUCING THE SINGLE PORT DEVICE, A 12 MM ACCESSORY PORT WAS PLACED. PERIAORTIC LYMPH NODE DISSECTION WAS INITIATED AND CARRIED DOWN INTO DEEP PELVIS. THE RECTUM WAS FULLY MOBILIZED, AND ON-TABLE FLEXIBLE SIGMOIDOSCOPY WAS PERFORMED TO ENSURE NEGATIVE MARGINS. THE RECTUM WAS DIVIDED WITH FIRING OF THE 60 MM LINEAR STAPLER (NON-ROBOTIC). NEXT, THE BOWEL WAS DIVIDED WITH THE VESSEL SEALER DEVICE AND AN ENDOLOOP WAS PLACED TO PREVENT INTRALUMINAL SPILLAGE. AT THIS JUNCTURE, THE SPECIMEN WAS EXTRACORPOREALIZED THOUGH THE SINGLE PORT AND THE ANVIL WAS PLACED TO THE CIRCULAR STAPLER (SIZE 29). THIS WAS SECURED TO THE SIGMOID LEFT COLON WITH A PURSESTRING SUTURE AND ENDOLOOP. NEXT, A PRIMARY COLORECTAL ANASTOMOSIS WAS PERFORMED USING THE ECHELON POWER STAPLER. THE DONUTS WERE CHECKED, AND THEY WERE INTACT. OVERSEWING VICRYL SUTURE WAS PLACED. DIRECT FLEXIBLE SIGMOIDOSCOPE REVEALED A PATENT COLORECTAL ANASTOMOSIS. THE INSUFFLATION TEST REVEALED NO EVIDENCE OF BUBBLES OR LEAKS. SUBSEQUENTLY THE PORTS WERE REMOVED, AND CLOSURE WAS PERFORMED. THE SUBJECT DID NOT EXPERIENCE ANY INTRAOPERATIVE COMPLICATIONS, AND THERE WAS NO CONVERSION TO OPEN SURGERY, ROBOTIC MULTIPORT OR LAPAROSCOPIC PROCEDURES. THE POSTOPERATIVE PATHOLOGICAL DIAGNOSIS WAS ADENOCARCINOMA OF THE UPPER RECTUM. HE TOLERATED THE PROCEDURE WELL. POSTOPERATIVELY, HE HAD RETURN OF BOWEL FUNCTION, TOLERATED A REGULAR DIET AND PAIN CONTROL WAS ACHIEVED. LOVENOX 40 MG WAS GIVEN DAILY DURING THE POSTOPERATIVE PERIOD AND STOPPED AT THE TIME OF DISCHARGE. HE WAS DISCHARGED TO HOME ON POSTOPERATIVE DAY-POD 2 ((B)(6) 2021) FOLLOWING AN UNCOMPLICATED POSTOPERATIVE COURSE AND WAS ADVISED TO RESUME ELIQUIS FROM (B)(6) 2021. ON (B)(6) 2021, THE SUBJECT PRESENTED TO THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF ABDOMINAL PAIN AND BACK PAIN, WHICH WORSENED ON EXERTION. A CT SCAN OF THE ABDOMEN AND PELVIS SHOWED HYPERDENSE FLUID COLLECTION IN THE PRESACRAL AREA CONSISTENT WITH POSTOPERATIVE HEMATOMA FOLLOWING LOW ANTERIOR RESECTION, LYMPH NODE DISSECTION AND PRIMARY COLORECTAL ANASTOMOSIS FOR UPPER RECTAL ADENOCARCINOMA. IT WAS NOTED THAT THE SUBJECT HAD NOT RESTARTED ANTICOAGULATION. A FLEXIBLE SIGMOIDOSCOPY WITH TRANSRECTAL DRAINAGE WAS PERFORMED. THERE WAS NO EVIDENCE OF INFECTION. HE WAS ADMITTED AND GIVEN PAIN MEDICATION FOR PAIN CONTROL AND IV FLUIDS. SUBSEQUENT BLOOD CULTURE WAS NEGATIVE AT 12 HOURS. AFTER IMPROVEMENT OF HIS PAIN AND ABILITY TO TOLERATE A DIET WAS NOTED, THE SUBJECT WAS DISCHARGED TO HOME ON (B)(6) 2021. DURING A FOLLOW UP VISIT ON (B)(6) 2021, IT WAS NOTED THAT FLEXIBLE SIGMOIDOSCOPY PERFORMED THE PREVIOUS WEEK REVEALED A CONTAINED PERIANASTOMOTIC SINUS. THE SUBJECT REPORTED BACK PAIN AND PERSISTENT LOOSE STOOLS. FLEXIBLE SIGMOIDOSCOPY WAS DONE, AND IT WAS NOTED THAT THE HEMATOMA HAD DECOMPRESSED INTO THE ANASTOMOSIS AND RESULTED IN THE APPARENT PERIANASTOMOTIC SINUS. FREQUENT STAGED FLEXIBLE SIGMOIDOSCOPIES WERE RECOMMENDED TO KEEP THE CAVITY CLEAN AND FREE OF DEBRIS TO ALLOW FOR HEALING OF THE CAVITY. A SUBSEQUENT FOLLOW UP SIGMOIDOSCOPY ON (B)(6) 2021 ALSO NOTED ANASTOMOTIC LEAK OF THE INTESTINE. ON ADVANCING UP TO THE ANASTOMOSIS, THE HEALING PROCESS WAS NOTED. IRRIGATION AND SUCTIONING OF MILKY-WHITE OPAQUE FLUID WERE DONE AFTER BACKING INTO THE ANASTOMOSIS. THE POSTERIOR DEHISCENCE OF THE ANASTOMOSIS WAS GRANULATING AND HEALING. DURING THE FLEXIBLE SIGMOIDOSCOPY ONE WEEK LATER ((B)(6) 2021), IRRIGATION WAS DONE AFTER ADVANCING PROXIMAL TO THE ANASTOMOSIS AND THE MUCOSA WAS OBSERVED TO BE HEALTHY. ON RETURNING TO THE ANASTOMOSIS, THERE APPEARED TO BE TWO SMALL DEFECTS AND CAVITY IN THE AREA BEHIND IT. SIGNIFICANTLY LESS AMOUNT OF MILKY WHITE FLUID WAS EXPRESSED ON IRRIGATION. FOLLOW UP AFTER 2 WEEKS WITH FLEXIBLE ENDOSCOPY WITH POSSIBLE CAUTERIZATION OF THE CAVITY WAS ADVISED. THE STUDY INVESTIGATOR CLASSIFIED THE PRIMARY AE OF OTHER: HEMATOMA OF PRESACRAL SPACE AS A SERIOUS ADVERSE EVENT (SAE) WITH (B)(6) 2021 AS THE DATE OF ONSET AND RESOLUTION ON (B)(6) 2021. THE INVESTIGATOR REPORTED THE SAE AS DEFINITELY RELATED TO THE LAR PROCEDURE, PROBABLY RELATED TO THE UNDERLYING DISEASE, AND NOT RELATED TO THE STUDY DEVICE." }, { "mdr_text_key": "294644358", "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. THE CAUSE OF THE POST-OPERATIVE COMPLICATIONS IS UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. THE INJURY WAS INITIALLY REPORTED TO THE FDA IN THE IDE ANNUAL PROGRESS REPORT (G200060 / R002)." }, { "mdr_text_key": "331599447", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ON 10-AUG-2022, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION ABOUT THE REPORTED EVENT: ON 02-NOV-2021, THE PATIENT REPORTEDLY DEVELOPED POST-OPERATIVE LUMBER SPINAL STENOSIS WITH NEUROGENIC CLAUDICATION." }, { "mdr_text_key": "331599448", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "329695920", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION CAN BE FOUND IN FIELDS: G3, G6, H2, AND H10. SUBJECT 700-01 ¿ PROCEDURE INDICATION WAS FOR BENIGN TUMOR (NEOPLASTIC EPITHELIAL POLYPS, VILLOUS, TUBULOVILLOUS ADENOMA), THE SUBJECT HAD AN EXTRACORPOREAL APPROACH ANASTOMOSIS, END TO END ANASTOMOSIS SINGLE LAYER USING A LAPAROSCOPIC CIRCULAR STAPLER, THE SUBJECT DID NOT HAVE A DIVERTING ILEOSTOMY. THE DATE OF THE RESOLUTION OF THE PRESACRAL HEMATOMA AE HAS BEEN CONFIRMED AS (B)(6)2021. FOLLOWING A REVIEW OF THE CASE, THE INVESTIGATOR CLARIFIED THAT A DOCUMENTATION ERROR OCCURRED. THE INVESTIGATOR CONFIRMED THERE WAS NO TRUE ANASTOMOTIC LEAK, THE FINDING WAS DEHISCENCE WITHOUT A LEAK. THE STUDY INVESTIGATOR REPORTED THE DEHISCENCE WITHOUT A LEAK AS A PRIMARY AE CLASSIFIED AS SURGICAL SITE/WOUND INFECTION/DISRUPTION WITH ONSET ON (B)(6) 2021 AND RESOLUTION ON (B)(6) 2022 AS NOT RELATED TO THE SP SURGICAL SYSTEM, AND DEFINITELY RELATED TO THE UNDERLYING DISEASE AND TO THE LAR PROCEDURE." }, { "mdr_text_key": "329695921", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "332304348", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "332304349", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING SECTIONS: G3, G6, H2 AND H10. ON 12-SEP-2022, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION ABOUT THE REPORTED EVENT: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED LOWER ANTERIOR RESECTION PROCEDURE, THE PATIENT EXPERIENCED AN ADVERSE EVENT NOT RELATED TO THE OPERATION. THE ISSUE OCCURRED AFTER THE PATIENT SLIPPED AND FELL ON (B)(6) 2021. INITIAL MRI WAS PERFORMED ON (B)(6) 2021. THE PATIENT WAS SEEN BY AN ORTHOPEDIC SURGEON, WHO DETERMINED THAT THE FALL RESULTED IN LOWER BACK PAIN. THE PATIENT REPORTED THAT THIS PAIN IMPROVED SOMEWHAT WITH PHYSICAL THERAPY AND HAD NO RADICULAR SYMPTOMS. FOLLOWING THE ROBOTIC PROCEDURE ON (B)(6) 2021, THE PATIENT DEVELOPED RADICULAR FINDINGS OF DISCOMFORT IN THE LUMBAR SPINE AND LEFT BUTTOCK PAIN WITH RADIATION TO HIS LEFT THIGH, DOWN THE LATERAL SIDE TO JUST BELOW THE KNEE. A PRESACRAL HEMATOMA WAS DISCOVERED ON (B)(6) 2021, WAS DRAINED, AND RESOLVED BY (B)(6) 2021 BUT THE PAIN PERSISTED. THE PATIENT MET WITH THE ORTHOPEDIC SURGEON ON (B)(6) 2021, WHO PRESCRIBED MEDROL DOSEPAK, AND WAS SENT TO IMAGING FOR FURTHER EVALUATION. MULTIPLE CT SCANS, MRIS, AND AN X-RAY WERE PERFORMED ON THE SAME DAY. THE PATIENT RETURNED FOR ORTHOPEDIC FOLLOW-UP ON (B)(6) 2021 TO DISCUSS THE RADIOLOGY FINDINGS AND INFORMED ORTHOPEDIC SURGEON THAT SIGNIFICANT IMPROVEMENT WAS FELT WITH THE STEROID PACK BUT WAS STILL EXPERIENCING A SHOOTING PAIN DOWN THE LEFT LEG. BASED ON THE DISCUSSION, THE PATIENT WAS TREATED ON (B)(6) 2021 WITH AN OUTPATIENT TRANSFORAMINAL APPROACH LEFT L3-4 AND LEFT L4-5 EPIDURAL STEROID (NERVE ROOT BLOCK) INJECTION WITH 1.5ML KENALOG 40MG/ML AND 1.5ML LIDOCAINE 1% WITHOUT EPINEPHRINE. SYMPTOMS HAD RESOLVED BY (B)(6) 2021 ORTHOPEDIC FOLLOW-UP. THE PATIENT WAS DIAGNOSED WITH LUMBAR SPINAL STENOSIS SIGNIFICANT AT L3-4 AND L4-5 WITH NEUROGENIC CLAUDICATION SECONDARY TO A TRAUMA, UNRELATED TO DA VINCI XI OR THE ROBOTIC PROCEDURE." } ], "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": "06/13/2022;09/09/2022;10/11/2022" } ] }