{ "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": "2955842-2013-03146", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130823", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20110316", "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", "Consumer" ], "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": "410226", "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": "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": "TX", "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": "20130823", "sequence_number_treatment": [ "DA VINCI S SYS INSTRUMENTS, ACCESSORIES & ESU." ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "43 YR", "patient_sex": "", "patient_weight": "62", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Inflammation", "Hernia" ] } ], "distributor_city": "", "date_report": "20130725", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3305566", "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": "3593377", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT ON (B)(4) 2013 INTUITIVE SURGICAL RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE WITH BILATERAL-OOPHORECTOMY AND CYSTOSCOPY PROCEDURE ON (B)(6) 2011. ON (B)(6) 2011 THE PATIENT WAS ADMITTED INTO THE EMERGENCY ROOM OF ANOTHER HOSPITAL DUE TO WHAT THE PATIENT REPORTED AS EXPERIENCING ABDOMINAL PAIN. THE ATTENDING SURGEON SUSPECTED POSSIBLE ACUTE ABDOMINAL INFECTION AND DETECTED HERNIA AT THE TROCAR SITE. DURING PELVIC EXPLORATION THE SURGEON NOTED A LARGE AMOUNT OF FLUID AND SUSPECTED A URETERAL INJURY. THE PATIENT REQUIRED AN EXPLORATORY LAPAROTOMY, A CYSTOSTOMY, URETERAL AND BLADDER EXPLORATION, PLACEMENT OF BILATERAL URETERAL STENTS, AND AN APPENDECTOMY. THE PATIENT UNDERWENT THIS PROCEDURE WITHOUT ANY COMPLICATIONS AND SHE WAS NOTED TO HAVE REMARKABLE POST-OPERATIVE RECOVERY WITH NORMAL RETURN OF ALL BLADDER FUNCTION. THE PATIENT'S OPERATIVE REPORT (OP) REGARDING THE SURGERY DATE OF (B)(6) 2011 INDICATES THAT THE PATIENT'S PREOPERATIVE DIAGNOSIS NOTED TP HAVE UTERINE FIBROIDS AND PELVIC PAIN. DURING THE SURGICAL PROCEDURE IT WAS DISCOVERED THAT THE PATIENT UTERUS WAS ATTACHED TO THE ANTERIOR ABDOMINAL WALL WITH DENSE BANDS OF ADHESIONS COVERING THE FUNDUS TO THE ANTERIOR ABDOMINAL WALL, ENCASING THE BLADDER TO THE POINT WHERE THE BLADDER FLAP COULD NOT BE IDENTIFIED. THE OVARIES EXHIBITED CYSTS BILATERALLY AND APPEARED TO BE BENIGN. BASED ON THE INFORMATION INDICATED IN THE PATIENT'S OP REPORT, THERE WAS NO INDICATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE AND THERE WERE NO SURGICAL ANOMALIES ENCOUNTERED DURING THE SURGICAL PROCEDURE. AFTER COMPLETION OF THE PROCEDURE, ALL OF THE PATIENT'S PEDICLES WERE INSPECTED AND THE TROCARS WERE REMOVED UNDER DIRECT VISUALIZATION TO ENSURE HEMOSTASIS. THE PATIENT WOUNDS WERE THEN CLOSED. A CYSTOSCOPY WAS PERFORMED AND FOUND THAT THERE WAS NO TRAUMA TO THE PATIENT'S BLADDER. BOTH OF THE PATIENT'S URETERS WERE INSPECTED AND DOCUMENTED TO BE EJECTING INDIGO CARMINE STAINED URINE. THE PATIENT FINAL CYSTOSCOPY WAS NORMAL AND THE PATIENT'S URETHRA WAS INSPECTED. A FOLEY CATHETER WAS PLACED, THE PATIENT WAS TAKEN DOWN FROM THE LITHOMY POSITION, EXTUBATED AND TRANSPORTED TO THE RECOVERY ROOM IN SATISFACTORY CONDITION. PATIENT WAS DISCHARGED FROM THE HOSPITAL TO GO HOME ON (B)(6) 2011. THE PATIENT'S DISCHARGE REPORT ALLEGED THAT THE PATIENT HAD AN UNREMARKABLE POSTOPERATIVE COURSE WITH NORMAL RETURN OF BOWEL AND BLADDER FUNCTION. SHE VOIDED SUCCESSFULLY WITHOUT ANY PROBLEMS. THE PATIENT'S PROGRESS NOTES ALLEGED THAT THE PATIENT WAS ADMITTED INTO THE ER ON (B)(6) 2011 DUE TO SEVERE PAIN. A CT SCAN PERFORMED ON THE PATIENT SHOWED THAT THE PATIENT HAD FREE FLOWING FLUID IN HER PELVIS, A HERNIA AT A TROCAR SITE AND PROBABLE GALLSTONES. DURING THE LAPAROTOMY PROCEDURE, A LARGE TO MODERATE AMOUNT OF FLUID WAS ENCOUNTERED. THERE WAS A LARGE AMOUNT OF INFLAMMATION INVOLVING THE ENTIRE PELVIS. SEVERAL LOOPS OF LARGE AND SMALL BOWEL WERE MATTED DOWN ON THE PELVIS AND THE APPENDIX WAS AT THE CENTER OF THIS. THE APPENDIX WAS INFLAMED, BUT IT APPEARED MORE LIKELY TO BE SECONDARY TO PERIAPPENDICITIS. CAREFUL INSPECTION OF THE PATIENT'S SIGMOID COLON FOUND NO INJURY AND THERE WAS NO EVIDENCE OF FECAL MATERIAL OR ANY INFLAMMATORY FLUID. THE SMALL BOWEL WAS ALSO INSPECTED AND THERE WAS NO EVIDENCE OF INJURY. INSPECTION OF THE PATIENT'S LEFT INFUNDIBULOPELVIC LIGAMENT REGION FOUND THAT THERE WAS A LARGE INFLAMMATORY REACTION AND APPEARED TO BE CLEAR FLUID EMANATING FROM THE REGION OF THE LEFT URETER. THERE WAS ALSO AN INCARCERATED LEFT LOWER QUADRANT TROCAR SITE HERNIA WITH SEGMENTAL OMENTUM. THE HERNIA WAS REDUCED AND A SMALL AREA OF NECROSIS IN THE OMENTUM WAS EXCISED AND LIGATED AND THE TROCAR SITE HERNIA WAS REPAIRED. AN APPENDECTOMY WAS ALSO PERFORMED. A INTRAVENOUS PYELOGRAPHY (IVP) WAS PERFORMED AND NO OBVIOUS EXTRAVASATION WAS IDENTIFIED. UPON OPENING THE PATIENT'S BLADDER, BLUE DYE WAS OBSERVED. AFTER EXPLORATION WAS COMPLETED, THERE STILL APPEARED TO BE FLUID ROLLING UP, PARTICULARLY FROM THE LEFT URETERAL REGION WHERE THERE APPEARED TO BE INFLAMMATION. STENTS WERE PLACED. THE PATIENT TOLERATED THE PROCEDURE WELL, WAS EXTUBATED AND TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION." }, { "mdr_text_key": "11017451", "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 OPERATIVE REPORTS DO 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. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE OF (B)(6) 2011 FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI SI SURGICAL HYSTERECTOMY PROCEDURE WITH A BILATERAL-OOPHORECTOMY." } ], "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": "" } ] }