{ "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": "2955842-2013-03071", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130816", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120630", "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": "20130819", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "396826", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130816", "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "GA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250827", "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": "20130816", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "36 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Laceration(s)", "Urinary Tract Infection" ] } ], "distributor_city": "", "date_report": "20130613", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3293493", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130613", "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": "3836699", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED A LEGAL COMPLAINT CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2012. ACCORDING TO THE PATIENT'S MEDICAL RECORDS, SHE SUSTAINED A SMALL RENT/TEAR IN THE POSTERIOR WALL OF THE BLADDER. ISI HAS REVIEWED THE MEDICAL RECORDS FOR THE PATIENT. BASED ON THE OPERATIVE REPORT OF THE HYSTERECTOMY PROCEDURE PERFORMED ON (B)(6) 2012, THERE IS NO INDICATION THAT A MALFUNCTION OF THE DA VINCI SI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THE SURGEON INDICATED THAT AFTER CLOSING OFF THE VAGINAL CUFF WITH THE SUTURE, WE THEN PLACED INDIGO CARMINE IN THE PATIENT'S VESSELS. THE SURGEON ALSO INDICATED, WE THEN PERFORMED A CYSTOSCOPY AFTER WE REMOVED ALL THE TROCARS UNDER DIRECT VISUALIZATION. AT THE CYSTOSCOPY, BOTH URETERS WERE NOTED TO BE EJECTING INDIGO CARMINE. WE THEN SAW A SMALL LITTLE HOLE, PIN SIZE HOLE. THE OPERATIVE REPORT INDICATED THAT AN INTRAOPERATIVE CONSULT WAS PERFORMED BY A SURGEON FROM UROLOGY AND IT WAS CONFIRMED THAT THERE WAS AN INCIDENTAL CYSTOTOMY. THE PATIENT'S INCISION SITES WERE THEN REOPENED AND 2 ROBOTIC TROCARS WERE USED IN THE LATERAL PORTS AND THEN A MIDLINE CAMERA PORT. THE UROLOGY SURGEON REPAIRED THE BLADDER INJURY BY PERFORMING A STANDARD LAPAROSCOPIC INTERRUPTED SUTURE JUST ABOVE THIS AREA ON THE BLADDER TO USE AS A HOLDING STITCH. THE SURGEON THEN PERFORMED IDENTICAL STITCHING, ONCE WE IDENTIFIED THE ACTUAL HOLE, BY LIFTING UP ON THE BLADDER ON THE HOLDING STITCH. TWO STITCHES WERE PLACED THROUGH THIS AND WERE TIED DOWN USING SURGEON'S KNOTS. A REPEAT CYSTOSCOPY WAS THEN PERFORMED AND IT WAS REVEALED THAT PART OF THE BLADDER WALL WAS TEARING WITH TYING DOWN OF THE KNOTS, INDICATING VERY FRAGILE TISSUE. THE SURGEON NOTED IN THE OPERATIVE REPORT THAT THERE HAD BEEN OVERALL A DECENT CLOSURE OF THE BLADDER, AND WITH FILLING THE BLADDER WITH IRRIGATION, THE BLADDER WAS ABLE TO HOLD THE MAJORITY OF IT. HE FURTHER NOTED THAT THEY FELT LIKE THIS CLOSURE BE SUFFICIENT GIVEN THE LOCATION, THE SIZE, AND THE OVERALL BULKING UP OF THE TISSUE BEHIND IT WITH THE STITCHES. A FOLEY CATHETER WAS THEN PLACED IN THE PATIENT AND THE BLADDER WAS DRAINED. THERE WERE NO REPORTED COMPLICATIONS DURING THE REPAIR OF THE PATIENT'S BLADDER. THE UROLOGY SURGEON NOTED IN THE PATIENT'S MEDICAL RECORDS THAT THE BLADDER INJURY WAS MOST LIKELY DUE TO ADHESIONS AND DIFFICULTY WITH DISSECTION DUE TO PREVIOUS CESAREAN SECTIONS AND PELVIC SURGERY. THE PATIENT WS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012. A POST-OPERATIVE VISIT ON (B)(6) 2012, WAS FOUND TO BE UNREMARKABLE. ON (B)(6) 2012, THE PATIENT HAD COMPLAINTS OF URETHRAL AND RIGHT LOWER QUADRANT PAIN AND DIARRHEA. THE PATIENT'S MEDICAL RECORDS INDICATE THAT A URINE CULTURE REVEALED ENTEROCOCCUS AND SHE WAS STARTED ON MACROBID, AN ANTIBIOTIC. NO ADDITIONAL CLINICAL RECORDS WERE AVAILABLE OR PROVIDED FOR REVIEW AFTER THE DATE OF (B)(6) 2012." }, { "mdr_text_key": "11009507", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INTUITIVE SURGICAL INC. (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. BASED ON THE REVIEW OF PATIENT'S MEDICAL RECORDS AND THE OPERATIVE REPORTS, THERE IS NO INDICATION THAT A MALFUNCTION OF THE DA VINCI SI SYSTEM, AND INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE HYSTERECTOMY PROCEDURE. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2012. NO SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE REPORTED SURGICAL PROCEDURE. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED A BLADDER INJURY DURING A DA VINCI SI SURGICAL PROCEDURE. HOWEVER, AT THIS TIME, IT IS UNKNOWN WHAT THE CAUSE IS OF THE PATIENT'S BLADDER INJURY. IT IS ALSO UNKNOWN IF THE DA VINCI SI SURGICAL SYSTEM CAUSED OR CONTRIBUTED TO THE PATIENT'S 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": "" } ] }