{ "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": "HOSPITAL", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2955842-2013-04928", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131101", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120615", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Other" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20131104", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "562319", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131101", "brand_name": "DA VINCI SI SURGICAL SYSTEM", "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL,INC.", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "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": "IS3000 A6.0P8", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "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" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250814", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20131101", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "50 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Anemia", "Fever", "Urinary Tract Infection", "Discomfort", "Bowel Perforation", "Test Result", "No Code Available" ] } ], "distributor_city": "", "date_report": "20131004", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3444163", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131004", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "11244881", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE FOR THE POST-OPERATIVE COMPLICATION(S) EXPERIENCED BY THE PATIENT. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT SUSTAINED POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI SI SURGICAL PROCEDURE." }, { "mdr_text_key": "3948249", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY WITH LEFT SALPINGO-OOPHORECTOMY, ABDOMINAL AND PELVIC ADHESIOLYSIS FOR PELVIC PAIN AND A FIBROID UTERUS, MENORRHAGIA ON (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES: HISTORY AND PHYSICAL ON (B)(6) 2012; DISCHARGE INSTRUCTIONS (B)(6) 2012, WOUND/OSTOMY CONSULT ON (B)(6) 2012, CARE MANAGEMENT CONSULT ON (B)(6) 2012, GENERAL EVALUATION-PHYSICAL THERAPY ON (B)(6) 2012, REHABILITATION MEDICINE CONSULTATION ON (B)(6) 2012, INTERNAL MEDICINE CONSULTATION & CARDIOLOGY CONSULTATION ON (B)(6) 2012, DISCHARGE SUMMARY ON (B)(6) 2012 THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. DUE TO THE EXTENSIVE AMOUNT OF ADHESIONS INCLUDING COLON THAT WAS ADHERED TO THE ANTERIOR ABDOMINAL WALL, INITIAL OPEN SUPRAUMBILICAL ACCESS TO THE ABDOMEN FAILED AND ACCESS WAS CREATED IN THE LUQ BY MEANS OF A VISIBLE PORT. IT TOOK AROUND 1.5 HOURS OF ADHESIOLYSIS AND TO DETACH THE SMALL BOWEL AND COLON FROM THE ANTERIOR ABDOMINAL WALL AND THE GENITO-URINARY ORGANS IN THE PELVIS BY USING A SHARP SCISSOR TECHNIQUE. SUBSEQUENTLY, AFTER GAINING ACCESS TO THE PELVIS, THE UTERUS WAS MOBILIZED BY DESICCATING AND TRANSECTING THE LATERAL LIGAMENTS, UTERINE-VASCULAR PEDICLES AND A CIRCUMFERENTIAL COLPOTOMY WAS CARRIED OUT. THE LEFT URETER WAS VISUALIZED. THE SPECIMEN WAS REMOVED TRANSVAGINALLY AND THE VAGINAL CUFF CLOSED USING SUTURE LIGATURES OF 0 VICRYL. INDIGO CARMINE WAS ADMINISTERED INTRAVENOUSLY AND A DIAGNOSTIC CYSTOSCOPY CONFIRMED BILATERAL URETERAL PATENCY. THE PATIENT WAS DISCHARGED HOME AFTER UNEVENTFUL POSTOPERATIVE COURSE ON (B)(6) 2012. THE PATIENT STARTED TO HAVE SOME DISCOMFORT ON (B)(6) 2012, WHICH APPEARED TO BE FAIRLY ROUTINE POSTOPERATIVE LAPAROSCOPIC GAS DISCOMFORT. ON (B)(6) 2012, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF SEVERE SHARP PAIN AND HAD AN EPISODE OF EMESIS. THE PATIENT WAS ADMITTED TO AN ER WHERE SHE PRESENTED WITH ACUTE PERITONEAL SIGNS AND THE CONCERN FOR POTENTIAL BOWEL INJURY WITH FREE INTRA ABDOMINAL FLUID AND A PNEUMOPERITONEUM IN HER CT ABD/PELVIS. ON (B)(6) 2012, SHE UNDERWENT AN EXPLORATORY LAPAROTOMY WITH ENTERECTOMY AND ENTEROENTEROSTOMY FOR A SMALL BOWEL ENTEROTOMY. INSPECTION REVEALED A SMALL ENTEROTOMY APPROXIMATELY 2 MM IN SIZE IN THE SMALL BOWEL WITH A SIGNIFICANT AMOUNT OF CLOUDY, SOMEWHAT BILIOUS-STAINED INTRAABDOMINAL FLUID. POSTOPERATIVELY, THE PATIENT HAD SOME RESPIRATORY ISSUES FOR WHICH SHE WAS TRANSFERRED TO THE PULMONARY CARE UNIT. SHE DEVELOPED A PHYSIOLOGIC SINUS TACHYCARDIA THAT WAS RELATED TO FEVER, ANEMIA, FLUID BALANCE AS WELL AS A POSSIBLE RESPONSE TO STRESS RELEASE OF CATECHOLAMINES. SHE REQUIRED A WOUND THERAPY WITH VACUUM-ASSISTED CLOSURE FOR A WOUND INFECT AND A UTI WAS TREATED. A REHAB EVALUATION PRIOR TO DISCHARGE REVEALED A MULTIFACTORIAL GAIT DYSFUNCTION AND SELF-CARE DYSFUNCTION BUT SHE DIDN'T QUALIFY FOR AN INPATIENT REHAB FACILITY. DISCHARGE HOME IN GOOD GENERAL CONDITIONS WITH HOME HEALTH ARRANGEMENTS ON (B)(6) 2012. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THE DATE OF DISCHARGE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }