{ "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": "2955842-2013-03167", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130823", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20101215", "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": "409874", "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": "", "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": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "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": "20130823", "sequence_number_treatment": [ "DA VINCI SI SYSTEM, INSTRUMENTS, ACCESSORIES & ES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "50 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Incontinence", "Abnormal Vaginal Discharge" ] } ], "distributor_city": "", "date_report": "20130725", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3305671", "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": "18854022", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT, ON (B)(6) 2013 INTUITIVE SURGICAL RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHOSE BLADDER WAS REPORTEDLY INJURED DURING A DA VINCI SI HYSTERECTOMY AND BILATERAL OOPHORECTOMY ON (B)(6) 2010. THE INADVERTENT DAMAGE TO THE PATIENT'S BLADDER WAS REPAIRED AND THE SURGICAL PROCEDURE WAS COMPLETED. THE OPERATIVE REPORT FOR THE PATIENT'S FOR THE SURGERY DATE OF (B)(6) 2010 INDICATED THAT AN INADVERTENT CYSTOTOMY APPROXIMATELY 2 CM WAS CREATED AND WAS INSTANTLY RECOGNIZED AND REPAIRED WITH SUTURES. INDIGO CARMINE WAS ADMINISTERED TO THE PATIENT AND THERE WAS NO PASSAGE OF DYE INTO THE PERITONEAL CAVITY NOTED AFTER THE COMPLETING THE REPAIR. REPORTEDLY, THE VAGINAL CUFF WAS COMPLETED AND WAS OVERSEWN WITH A GOOD SEAL. HEMOSTASIS WAS CHECKED AND ASSURED. THE PATIENT'S URETERS WERE INSPECTED AND NOTED TO BE IN THEIR NORMAL ANATOMICAL POSITIONS BILATERALLY. THE PROCEDURE WAS COMPLETED A LEAF OF INTERCEED WAS PLACED OVER THE VAGINAL CUFF. THE PATIENT WAS CLOSED, EXTUBATED AND TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. THERE WERE NO OTHER COMPLICATIONS NOTED. THE PATIENT'S HISTORY AND PHYSICAL REPORT STATED THAT DURING A POST-OP FOLLOW UP ON (B)(6) 2011, THE PATIENT COMPLAINED THAT 3 DAYS POST OP SHE BEGAN TO EXPERIENCING INCREASED FLUID FROM THE VAGINA WHEN SHE STANDS, WALKS, SNEEZES OR COUGHS. THE PATIENT WAS CONCERNED THAT THESE MAY BE FROM HER BLADDER. A CT CYSTOGRAM DOCUMENTED VESICOVAGINAL FISTULA. THE PATIENT'S DISCHARGE SUMMARY STATED THAT THIS POSSIBLY WAS DUE TO HER INTERVENTION PROCEDURE IN (B)(6) 2010. REPORTEDLY, THE PATIENT WAS INSTRUCTED TO MAINTAIN HER FOLEY CATHETER FOR ANOTHER 4 TO 6 WEEKS AND THEN FOLLOW UP WITH THE UROLOGIST. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011. THE PATIENT'S MEDICAL RECORDS INDICATED THAT DURING A FOLLOW-UP EXAMINATION, THE PATIENT REPORTED THAT SHE FELT THAT SHE HAD AN INFECTION. A CYSTOSCOPY WAS PERFORMED ON THE PATIENT AND A URINALYSIS REVEALED THAT THE PATIENT DID NOT HAVE AN INFECTION. REPORTEDLY, THE PATIENT UNDERWENT A CYSTOSCOPY, BILATERAL RETROGRADE PYELOGRAMS, ABDOMINAL EXPLORATION WITH LYSIS OF ADHESION, CLOSURE OF VESICO-VAGINAL FISTULA WITH OMENTAL GRAFT INTERPOSITION, AND SP TUBE REPLACEMENT. DURING THE PROCEDURE THERE WAS NO URETERAL EXTRAVASATION, HYDRONEPHROSIS OR FILLING DEFECT NOTED. AFTER COMPLETION OF THE PROCEDURE GOOD HEMOSTASIS WAS ASSURED. THE PATIENT WAS CLOSED AND THE PATIENT WAS TRANSFERRED TO THE PACU IN STABLE CONDITION AFTER EXTUBATION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011. NO ADDITIONAL INFORMATION WAS PROVIDED SINCE THE PATIENT'S LAST DISCHARGE." }, { "mdr_text_key": "19061292", "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. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THE DOCUMENTATION PROVIDED DOES NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY. ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION FROM THE RISK MANAGEMENT GROUP AT THE SITE, HOWEVER AS OF THE DATE OF THIS REPORT NO RESPONSE HAS BEEN RECEIVED. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED AN INJURY DURING A DA VINCI SI HYSTERECTOMY AND BILATERAL OOPHORECTOMY AND EXPERIENCED POST SURGICAL COMPLICATIONS POST-OPERATIVELY." } ], "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": "" } ] }