{ "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": "2955842-2013-03526", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130912", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20110913", "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": "20130913", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "458243", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130912", "brand_name": "DA VINCI 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": "", "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": "20250810", "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": "20130912", "sequence_number_treatment": [ "DA VINCI SURGICAL SYSTEM, INSTRUMENTS, ACCESSORIE" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "43", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Adhesion(s)", "Peritonitis", "Bowel Perforation", "Test Result" ] } ], "distributor_city": "", "date_report": "20130815", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3346175", "removal_correction_number": "", "number_devices_in_event": "", "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": "3807034", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SURGICAL PROCEDURE TO REPAIR THE PATIENT'S RECURRENT VESICO-VAGINAL FISTULA ON (B)(6) 2011. THE MEDICAL RECORDS INDICATE THAT THE PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE IN (B)(6) 2011. NO INFORMATION WAS PROVIDED AS TO WHERE THIS WAS PERFORMED OR WHAT SURGICAL APPROACH WAS USED. ACCORDING TO THE PATIENT'S MEDICAL RECORDS, THE PATIENT DEVELOPED A VESICOVAGINAL FISTULA AT AN UNSPECIFIED TIME AFTER THE HYSTERECTOMY PROCEDURE WAS PERFORMED. IN (B)(6) 2011, A SURGEON ATTEMPTED A ROBOTIC REPAIR OF THE VESICOVAGINAL FISTULA. NO MEDICAL INFORMATION WAS PROVIDED ON THIS PROCEDURE. THE PATIENT CONTINUED TO HAVE A VESICOVAGINAL FISTULA, AND ON (B)(6) 2011, THE PATIENT UNDERWENT ROBOTIC-ASSISTED REPAIR OF A RECURRENT VESICOVAGINAL FISTULA, LYSIS OF ADHESIONS, ENTEROLYSIS, CYSTOSCOPY, AND PLACEMENT OF BILATERAL OPEN-ENDED URETERAL CATHETERS. THE OPERATIVE REPORT FOR THIS PROCEDURE DESCRIBES LYSIS OF BOWEL ADHESIONS AND RETRACTION OF THE BOWEL TO KEEP IT OUT OF THE SURGICAL FIELD. TWO DAYS POST-OP, MEDICAL RECORDS INDICATE THE PATIENT DEVELOPED SIGNS OF PERITONITIS WITH ELEVATED WHITE BLOOD CELLS. ON (B)(6) 2011, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY, LYSIS OF ADHESIONS, AND RESECTION OF THE SMALL BOWEL AND PROXIMAL ILEUM WITH PRIMARY ANASTOMOSIS SECONDARY TO SMALL BOWEL PERFORATION. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2011 WITH A FOLEY CATHETER AND WITH 2 URETERAL CATHETERS. NO COMPLICATIONS WERE FOUND DURING POST-OP VISITS ON (B)(6) 2011, AND MEDICAL RECORDS INDICATE THE INCISIONS WERE HEALING WELL AND THE FOLEY CATHETER WAS DRAINING CLEAR, YELLOW URINE. A FOLLOW-UP VISIT ON (B)(6) 2011, REPORTED THE PATIENT WAS DOING WELL. THE PATIENT WAS EVALUATED ON (B)(6) 2012, FOR INCISIONAL PAIN. NO EVIDENCE OF A HERNIATION OR OBSTRUCTION WAS FOUND. THE PATIENT WAS TREATED WITH ORAL PAIN MEDICATIONS." }, { "mdr_text_key": "11179560", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. THE PATIENT'S MEDICAL RECORDS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. ISI HAS ATTEMPTED TO CONTACT THE PATIENT'S ATTORNEY TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENTS; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. IT IS UNKNOWN WHAT SITE THE REPORTED DA VINCI SURGICAL PROCEDURE WAS PERFORMED AT OR WHAT DA VINCI SYSTEM SERIAL WAS USED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT SUSTAINED A BOWEL INJURY AFTER UNDERGOING 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": "" } ] }