{ "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": "2955842-2013-04807", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20131031", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130429", "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": "20131101", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "560308", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131031", "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": "IS2000 A5.1P7", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "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": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250813", "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": "20131031", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES&ES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "46 YR", "patient_sex": "", "patient_weight": "64", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Nausea", "Pleural Effusion", "Swelling", "Vomiting", "Abdominal Cramps" ] } ], "distributor_city": "", "date_report": "20131002", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3440861", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131002", "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": "3898650", "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 HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY FOR SEVERE DYSMENORRHEA, MENORRHAGIA AND UTERINE FIBROIDS ON (B)(6) 2013. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. 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. THE PATIENT RECEIVED 4 UNITS OF PACKED RED BLOOD CELLS PRIOR TO SURGERY. THE UTERUS WAS 12-14 CM IN SIZE AND GOOD CLOSURE OF THE VAGINAL CUFF WAS REPORTED AS GOOD. INSPECTION OF THE PELVIS REVEALED NO EVIDENCE OF BLEEDING. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE RECOVERY ROOM IN GOOD CONDITION. BLOOD LOSS WAS APPROXIMATELY 125ML. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY, FOR A 2 DAY HOSPITAL STAY. ON (B)(6) 2013 THE PATIENT PRESENTED WITH PERSISTENT NAUSEA AND BILIOUS VOMITING. THE PATIENT REPORTED CRAMPING AND ABDOMINAL PAIN IN ADDITION TO ABDOMINAL GURGLING. A CT SCAN FOUND MULTIPLE MODERATELY DILATED FLUID FILLED SMALL BOWEL LOOPS AND MINIMAL BILATERAL PLEURAL EFFUSIONS WITH MILD BIBASILAR ATELECTASIS. A TRACE AMOUNT OF ASCITES WAS PRESENT. THROMBOSIS IN THE RIGHT OVARIAN VEIN WAS NOTED, AS WAS A BUILD UP OF FLUID IN THE LATERAL ANTERIOR ABDOMINAL WALL. ON (B)(6) 2013, THE PATIENT UNDERWENT A LAPAROSCOPIC PROCEDURE FOR LYSIS OF ADHESIONS AND ASPIRATION OF AN ABDOMINAL WALL SEROMA, WHICH WAS SENT FOR CULTURE. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED 4 DAYS LATER, ON (B)(6) 2013. ON (B)(6) 2013, THE PATIENT PRESENTED WITH URINARY INCONTINENCE AND RECURRENT NAUSEA WITH VOMITING. A CYSTOSCOPY REVEALED A URETEROVAGINAL FISTULA AND THE PLACEMENT OF A STENT WAS UNSUCCESSFUL SO A NEPHROSTOMY TUBE WAS PLACED. SHE WAS DISCHARGED ON (B)(6) 2013. ON (B)(6), SHE ENTERED THE HOSPITAL FOR A LEFT ROBOTIC-ASSISTED URETERAL RE-IMPLANTATION. MULTIPLE ADHESIONS WERE NOTED IN THE ABDOMEN, WHICH WERE LAPAROSCOPICALLY RELEASED PRIOR TO DOCKING OF THE ROBOT. THE LEFT URETER WAS EDEMATOUS AND WAS TRACED DOWN TO THE PELVIS. SINCE ENOUGH LENGTH COULD NOT BE OBTAINED, A BOARI FLAP WAS CREATED. NO EVIDENCE OF EXTRAVASATION FROM THE ANASTOMOSIS WAS NOTED POST-PROCEDURE. ESTIMATED BLOOD LOSS FROM THIS PROCEDURE WAS 100ML. HER CATHETER WAS REMOVED ON (B)(6) 2013. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THE NOTE REGARDING CATHETER REMOVAL." }, { "mdr_text_key": "11240721", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INTUITIVE SURGICAL RECEIVED A VOLUNTARY REPORT FROM THE FDA REGARDING THIS PATIENT. VOLUNTARY NUMBER: (B)(4). THE FOLLOWING WAS NOTED BY THE PATIENT ON THIS VOLUNTARY REPORT: \"I HAD A DA VINCI HYSTERECTOMY AND WAS SENT HOME AND WAS READMITTED TO DISCOVER MY RIGHT URETER WAS CUT IN HALF AND NOT DETECTED WHICH RESULTED IN A URINE SPILL IN MY BODY. AN ATTEMPT TO INSTALL A STENT WAS UNSUCCESSFUL AND I HAD YET ANOTHER MAJOR SURGERY TO REPAIR MY URETER AND INSTALL THE STENT WHICH RESULTED IN AN 8 INCH SCAR ON MY STOMACH DUE TO THE NEGLIGENCE OF THE DA VINCI HYSTERECTOMY.\" NO FURTHER INFORMATION WAS PROVIDED. ISI HAS ATTEMPTED TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT." }, { "mdr_text_key": "11342325", "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- SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE OPERATIVE REPORT INDICATED THAT AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE THE PATIENT SUFFERED A URETER INJURY." } ], "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": "11/08/2013" } ] }