{ "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": "2955842-2013-04917", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131101", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20100602", "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": "562770", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131101", "brand_name": "DA VINCI S 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 A5.1P8", "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": "20250812", "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 S SURG SYS INSTRUMENTS, ACCESSORIES & ESU" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "46 YR", "patient_sex": "", "patient_weight": "73", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Laceration(s)", "Stenosis", "Injury" ] } ], "distributor_city": "", "date_report": "20131004", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3444123", "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": "3901075", "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 S TOTAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY, ABORTED DAVINCI LAPAROSCOPIC SACRAL COLPOPEXY, EXPLORATORY LAPAROTOMY WITH LEFT COMMON ILIAC VEIN REPAIR, ABDOMINAL SACRAL COLPOPEXY, IMPLANTATION OF SYNTHETIC Y MESH, SLING URETHROPEXY AND CYSTOSCOPY FOR UTEROVAGINAL PROLAPSE, URETHRAL HYPERMOBILITY, STRESS INCONTINENCE, INCOMPETENT PUBOCERVICAL FASCIA, INCOMPETENT RECTOVAGINAL FASCIA, ENDOMETRIOSIS, PELVIC CONGESTION SYNDROME, INTRAOPERATIVE LEFT COMMON ILIAC VEIN INJURY, TRIGONITIS, UMBILICAL HERNIA ON (B)(6) 2010. ISI WAS PROVIDED WITH 2 OPERATIVE REPORTS (GYN & VASCULAR). ADDITIONAL INFORMATION PROVIDED INCLUDED: A HANDWRITTEN, LIMITED H & P (B)(6) 2010, A DISCHARGE SUMMARY (B)(6) 2010 AND A ICU CONSULTATION NOTE ON (B)(6) 2010. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI S SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE SURGERY. THERE WAS REPORT OF AN INTRAOPERATIVE COMPLICATION (LEFT COMMON ILIAC VEIN INJURY). AFTER A STANDARD ROBOTIC ASSISTED HYSTERECTOMY WAS PERFORMED WITHOUT DIFFICULTIES, FURTHER SEPARATION OF THE PELVIC ORGANS WAS CARRIED OUT AND A Y MESH PLACED INTO THE ABDOMEN AND LAID OUT ON TOP OF THE VAGINAL CUFF. THE MESH WAS SEWN INTO THE VAGINAL CUFF. THE VAGINA WAS ELEVATED INTO THE SURGICAL FIELD AND THE Y MESH WAS ARRANGED IN THE PERITONEAL INCISION. ATTEMPTS WERE MADE TO ATTACH THE MESH TO THE SACRUM USING A PROTACKER. THERE WAS DIFFICULTY USING THE PROTACKER, WHEN PRESSURE WAS USED TO PUSH THE PROTACKER INTO THE SACRUM IT KEPT SLIPPING. RETRACTION OF THE TISSUE IN THIS AREA DID NOT AIDE IN PLACEMENT. INCREASED OOZING WAS NOTED IN THIS AREA. TWO TACKS WERE PLACED BUT BEGAN TO TEAR THE MESH. RETRACTION OF THE TISSUE WAS READJUSTED FOR BETTER VISUALIZATION. A 0 PROLENE WAS THEN PLACED THROUGH THE MESH AND SACRAL LIGAMENTS. SOON AFTER THIS AND INCREASED BLEEDING WAS NOTED. THE TISSUE WAS ATTEMPTED TO BE GRASPED AND CAUTERIZED WITH THE BIPOLAR. THIS DID NOT CONTROL THE BLEEDING. THE BLEEDING WAS CONTROLLED WITH TAMPONADE BY COMPRESSION WITH THE SUCTION BUT UPON RELAXATION THE BLEEDING WAS AT AN INCREASED RATE THAN WAS CONSIDERED ACCEPTABLE, THEREFORE IMMEDIATE CONVERSION TO A LAPAROTOMY WAS PERFORMED. NOTED WAS A LACERATION TO THE POSTERIOR WALL OF THE LEFT COMMON ILIAC VEIN AT ITS CONFLUENCE OF ABOUT 3.5CM IN LENGTH. THE DEFECT WAS DIRECTLY REPAIRED WITH A 6-0 PROLENE SUTURE. DURING THIS TIME THE PATIENT WAS TRANSFUSED 2 UNITS PRBC. WITH THE VESSEL REPAIRED AND BLEEDING UNDER CONTROL THE REMAINDER OF THE CASE WAS PERFORMED AND THE MESH APPROPRIATELY FIXATED. AT THE END OF THE PROCEDURE AN URETHROCELE AND URETHRAL HYPERMOBILITY WAS CORRECTED TRANSVAGINALLY. ESTIMATED BLOOD LOSS: 2600 ML. HER PREOPERATIVE HEMOGLOBIN WAS 14.4 AND IN THE POSTOP AREA, HER HEMOGLOBIN DID DROP TO 12.8 AFTER THE 2 TRANSFUSIONS. SHE HAD BEEN STARTED ON A HEPARIN DRIP FOR PROPHYLAXIS DUE TO THE STENOSIS OF THE COMMON ILIAC VEIN AFTER THE VASCULAR SURGERY REPAIR. HER HEMOGLOBIN HAD BEEN FOLLOWED FOR THE NEXT 2 DAYS WHILE SHE WAS ON THE HEPARIN DRIP AND HER HEMOGLOBIN NOTED TO DROP TO 6. SHE RECEIVED ANOTHER 2 UNITS OF PACKED RBC'S AFTER THE LOVENOX DRIP HAD BEEN DISCONTINUED. AFTER THE BLOOD TRANSFUSIONS, HER HEMOGLOBIN CONTINUED TO INCREASE AND ON THE DAY OF DISCHARGE IT WAS 8.4. ON POSTOPERATIVE DAY 1, THE PATIENT WAS DOING WELL IN THE INTENSIVE CARE UNIT. HER RESPIRATORY INSUFFICIENCY WAS ALREADY RESOLVED AND SHE WAS DOING VERY WELL ON A WEANING TRIAL INDICATING THAT SHE WILL BE EXTUBATED SOON. THE PATIENT WAS ABLE TO BE ADVANCED TO A REGULAR DIET, A SWELLING IN THE LEFT LEG DECREASED ON THE DAY OF DISCHARGE AND A VOIDING TRIAL WAS SUCCESSFUL. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2010. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THE DATE OF DISCHARGE." }, { "mdr_text_key": "11251736", "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 SUSTAINED 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: THE PATIENT WAS 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": "" } ] }