{ "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": "2955842-2013-04912", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131101", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120405", "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": "563003", "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": [ "Device Operates Differently Than Expected", "Extrusion" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250808", "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": [ "DAV SI SURG SYS INSTRUMENTS, ACCESSORIES & ESU" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "65 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Fistula", "Laceration(s)", "Weakness", "Injury", "Test Result" ] } ], "distributor_city": "", "date_report": "20131004", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3444378", "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": "3900663", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY WITH BSO, UTEROSACRAL LIGAMENT SUSPENSION AND CYSTOSCOPY FOR PELVIC PRESSURE AND THICKENING OF THE ENDOMETRIAL LINING ON (B)(6) 2012. REPORTEDLY, THE PATIENT SUSTAINED A BOWEL INJURY. ISI WAS NOT PROVIDED WITH ANY ORIGINAL MEDICAL RECORDS INCLUDING OPERATIVE REPORT OR DISCHARGE SUMMARIES. ACCORDING TO THE INFORMATION PROVIDED, ON (B)(6) 2012, WHEN IT WAS DISCOVERED THAT THE PATIENT WAS STILL NOT GETTING BETTER GI AND SURGERY WERE CONSULTED. A SECOND CT WAS OBTAINED AND SHE WAS NOTED TO HAVE A POSSIBLE ENTEROTOMY IN THE LOWER COLON. ON (B)(6) 2012, SHE WAS TAKEN BACK TO THE OPERATING ROOM. THE SURGEON DID NOTE A RECTAL INJURY AND THIS WAS REPAIRED AND A PROTECTIVE DIVERTING COLOSTOMY WAS PLACED. POST OPERATIVELY THE PATIENT NEEDED TO BE IN THE ICU FOR SEVERAL DAYS. AN ACUTE MYOCARDIAL INFARCT WAS DIAGNOSED DURING THIS EPISODE. AFTER BEING TREATED WITH IV ANTIBIOTICS HER WHITE COUNT DID DIMINISH. A REHAB FACILITY WAS THEN CONSULTED ON (B)(6) FOR LONG TERM MANAGEMENT. THE PATIENT CONTINUED TO IMPROVE SLOWLY AND WAS ADVANCED IN HER DIET IN A VERY SLOW FASHION. SHE WAS TRANSFERRED TO A REHABILITATION FACILITY FOR TREATMENT OF GENERAL WEAKNESS AND CRITICAL ILLNESS MYOPATHY ON (B)(6) 2012 FOR COMPREHENSIVE INPATIENT REHABILITATION. DISCHARGE HOME ON (B)(6) 2012 AFTER GRADUAL IMPROVEMENT. REPORTEDLY ON (B)(6) 2012 THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY WITH REPAIR OF RECTAL LACERATION, DIVERTING COLOSTOMY, DRAINING OF INTRAABDOMINAL ABSCESS WITH PERITONEAL LAVAGE. THE LOCATION IN THE RECTUM CORRELATES WITH AN AREA THAT CAUSED SOME CONCERNS DURING ORIGINAL SURGERY AND CAUSED THE SURGEON TO PLACE A STITCH. ON (B)(6) 2012 THE PATIENT UNDERWENT A COLOSTOMY TAKE DOWN WITH NG TUBE PLACEMENT. FROM (B)(6) 2012 THE PATIENT'S RECTOVAGINAL FISTULA STATUS POST TAKEDOWN OF COLOSTOMY REQUIRED A DIVERTING ILEOSTOMY. ON (B)(6) 2013 THE PATIENT UNDERWENT AN ILEOSTOMY TAKEDOWN SECONDARY TO A COLOVAGINAL FISTULA." }, { "mdr_text_key": "11245762", "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 OF THE INJURY AND POST SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THE DOCUMENTATION PROVIDED DID NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE PATIENT SUSTAINED A BOWEL INJURY DURING A DA VINCI SURGICAL PROCEDURE." } ], "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": "" } ] }