{ "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": "2955842-2013-03288", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130830", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20121115", "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": "20130830", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "428902", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130830", "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": [ "Occlusion Within Device" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250805", "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": "20130830", "sequence_number_treatment": [ "DA VINCI SI SURG SYS INSTRUMENTS, ACCESS & ESU" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "47 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Injury", "Obstruction/Occlusion" ] } ], "distributor_city": "", "date_report": "20130801", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3319004", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130801", "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": "3841956", "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, INC.(ISI) RECEIVED INFORMATION INCLUDING THE MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2012 DUE TO RECURRENT CARCINOMA IN SITU OF THE CERVIX, FIBROIDS AND MENORRHAGIA. THERE WAS NO REPORT IN THE PATIENT'S OPERATIVE REPORT (OP) THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED AND THERE WAS NO INDICATION THAT THE PATIENT EXPERIENCED ANY INTRAOPERATIVE COMPLICATIONS. ACCORDING TO THE OP REPORT, THE PATIENT HAD A PREVIOUS RIGHT SALPINGECTOMY FOR ECTOPIC PREGNANCY AND THERE WAS SOME SCAR TISSUE FROM THE RIGHT OVARY TO THE UTERUS. THE PATIENT'S UTERUS WAS FOUND TO BE TOO LARGE TO REMOVE VAGINALLY, WHICH REQUIRED THAT THE UTERUS/CERVIX BE MORCELLATED AND THEN REMOVED. INSPECTION OF THE PATIENT'S ABDOMEN FOUND THAT ALL OF THE SURGICAL SITES WERE HEMOSTATIC. THE PATIENT WAS AWAKENED AND TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THE PATIENT REPORTEDLY TOLERATED THE PROCEDURE WELL. THE MEDICAL RECORDS RECEIVED BY ISI WERE NOT COMPLETE. BASED ON THE LIMITED INFORMATION PROVIDED, THE MEDICAL RECORDS SHOWED THAT THE PATIENT UNDERWENT A CYSTOGRAM ON (B)(6) 2012. THE CYSTOGRAM FOUND NO EVIDENCE OF A LEAK OR FISTULOUS CONNECTION WITH THE URINARY BLADDER AND A POST VOID IMAGE DEMONSTRATED NEAR COMPLETE EMPTYING OF THE BLADDER WITHOUT EVIDENCE OF LEAKAGE. ON (B)(6) 2012, THE PATIENT UNDERWENT A NEPHROSTOMY CATHETER TUBE PLACEMENT PROCEDURE, DUE TO AN INJURY OF THE DISTAL URETER ON THE LOWER RIGHT SIDE. ACCORDING TO THE PATIENT'S NEPHROSTOGRAM REPORT, IT WAS DISCOVERED THAT THE PATIENT HAD A OBSTRUCTION OF THE URETER SEVERAL CENTIMETERS BELOW THE LEVEL OF THE PELVIC BRIM AND ABOUT 5 CM FROM THE URETERAL VESICLE JUNCTION. IT WAS STATED THAT THE URETER APPEARED TO BE TOTALLY OCCLUDED AT THIS LEVEL AND THERE WAS SOME EXTRAVASATION OF CONTRAST WITHIN THIS REGION. AN ATTEMPT TO CROSS THE OBSTRUCTION WAS NOT POSSIBLE. THE SURGEON MADE THE DECISION TO LEAVE A 10 FRENCH NEPHROSTOMY CATHETER IN THE UPPER MOIETY KIDNEY FOR EXTERNAL DRAINAGE AND HAVE THE PATIENT RETURN IN 7 TO 10 DAYS TO RE-ATTEMPT TO CROSS THE AREA. NO COMPLICATIONS WERE OBSERVED AND NO SIGNIFICANT BLEEDING WAS NOTED." }, { "mdr_text_key": "11186739", "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 DOES NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY. ISI HAS CONTACTED RISK MANAGEMENT GROUP AT THE SITE TO GATHER ADDITIONAL INFORMATION; 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 FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INJURY SUSTAINED BY THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED AN INJURY DURING A DA VINCI SI HYSTERECTOMY 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": "" } ] }