{ "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": "2955842-2013-03143", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20130823", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120430", "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": "20130823", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "410309", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130823", "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": "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250811", "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": "20130823", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "39 YR", "patient_sex": "", "patient_weight": "58", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20130725", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3305540", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130725", "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": "11068088", "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. 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. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THE OPERATIVE REPORT DID NOT INDICATE THAT A MALFUNCTION OF THE DA VINCI SI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE LEGAL COMPLAINT ALLEGED THAT THE PATIENT SUSTAINED A VAGINAL CUFF DEHISCENCE AS A RESULT OF UNDERGOING A DA VINCI HYSTERECTOMY PROCEDURE. HOWEVER, AT THIS TIME, IT IS UNKNOWN HOW THE PATIENT'S BOWEL INJURY OCCURRED AND IF THE DA VINCI SURGICAL SYSTEM CAUSED OR CONTRIBUTED TO THE PATIENT'S INJURY." }, { "mdr_text_key": "3589736", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT, ON JULY 25TH, 2013 INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY, LEFT SALPINGO-OOPHORECTOMY, ADHESIOLYSIS, AND CYTOSCOPY PROCEDURE ON (B)(6) 2012. THE LEGAL COMPLAINT ALLEGED THAT THE PATIENT SUSTAINED VAGINAL CUFF DEHISCENCE AS A RESULT OF A ROBOTIC-ASSISTED HYSTERECTOMY. ACCORDING TO THE LEGAL COMPLAINT, MULTIPLE ADHESIONS WERE FOUND ON THE LEFT ABDOMINAL WALL, THE CUL-DE-SAC AND LEFT PELVIC GUTTER, AND AROUND THE LEFT ADNEXAL MASS DURING THE SURGERY. IN ADDITION, THE LEGAL COMPLAINT INDICATED THAT THE PROCEDURE WAS TOLERATED WELL AND NO COMPLICATIONS WERE NOTED. BASED ON THE OPERATIVE REPORT, A CYSTOSCOPY WAS PERFORMED AT THE CONCLUSION OF THE SURGICAL PROCEDURE WHICH CONFIRMED GOOD EFFLUX OF INDIGO CARMINE FROM BOTH URETERS. ALSO, IT WAS NOTED IN THE OPERATIVE REPORT THAT THERE WERE NO INJURIES TO THE BLADDER WALL AND THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. ON (B)(6) 2012, THE PATIENT WAS EVALUATED AT A CLINIC FOR COMPLAINTS OF HEAVY BLEEDING AND CLOTS, NOTED TO BE THE SECOND EPISODE OF BLEEDING. THE INFORMATION PROVIDED INDICATED THAT THE PATIENT WAS SEEN IN AN EMERGENCY ROOM (ER) THE PRECEDING WEEKEND FOR BLEEDING, HOWEVER, THE MEDICAL RECORDS RELATED TO THAT ER VISIT WERE NOT PROVIDED. UPON EXAMINATION, THE PHYSICIAN FOUND A 1CM CUFF DEFECT IN THE MIDLINE WITH VISIBLE CLOT AND INCREASED BLEEDING WITH MANIPULATION/EXAM. THE PHYSICIAN REPAIRED THE CUFF WITH SUTURES. DURING THE SURGERY, THE PHYSICIAN NOTED THAT A VAGINAL CUFF OPENING OF APPROXIMATELY 2-3 CM WITH BLEEDING FROM THE POSTERIOR CUFF WAS OBSERVED. AT AN UNSPECIFIED TIME SHORTLY AFTER THE (B)(6) 2012 SURGERY, AN INFERIOR VENA CAVA FILTER WAS PLACED DUE TO CONTRAINDICATION OF USE OF ANTICOAGULANT THERAPY IN THE PRESENCE OF ACTIVE BLEEDING. ON (B)(6) 2012, THE PATIENT UNDERWENT ANOTHER SURGICAL PROCEDURE BY ANOTHER SURGEON FOR REPAIR OF A COMPLETE MUCOSAL SEPARATION OF THE VAGINAL CUFF. THE SURGEON INDICATED THAT THE VAGINAL CUFF HAD COMPLETE SEPARATION OF THE MUCOSA WITH INTACT SUTURES IN THE POSTERIOR VAGINAL MUCOSA AND LACERATIONS DIRECTLY ACROSS FROM THE SUTURES SUGGESTING A POSSIBLE TRAUMATIC CAUSE OF THE CUFF SEPARATION. THE LEGAL COMPLAINT INDICATED THAT THE SURGEON DID NOT ELABORATE FURTHER ON HOW THIS TRAUMA COULD HAVE OCCURRED. THE POST-OPERATIVE RECORDS WERE NOT PROVIDED. ON (B)(6) 2012, THE INFERIOR VENA CAVA FILTER WAS REMOVED. THE LEGAL COMPLAINT SUGGESTED THAT THE VAGINAL BLEEDING WAS CONTROLLED AND HAD NOT RECURRED SINCE THE FINAL SURGERY." }, { "mdr_text_key": "22518826", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE LEGAL COMPLAINT ALLEGED THAT THE PATIENT SUSTAINED A VAGINAL CUFF DEHISCENCE AS A RESULT OF UNDERGOING A DA VINCI HYSTERECTOMY PROCEDURE. HOWEVER, AT THIS TIME, IT IS UNKNOWN IF THE DA VINCI SURGICAL SYSTEM CAUSED OR CONTRIBUTED TO THE PATIENT'S POST-SURGICAL COMPLICATION." } ], "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": "08/29/2013" } ] }