{ "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": "2955842-2013-04802", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131031", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20110824", "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": "20131101", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "560588", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131031", "brand_name": "DA VINCI S 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": [ "Device Operates Differently Than Expected" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250814", "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": "20131031", "sequence_number_treatment": [ "DA VINCI S SYSTEM INSTRUMENTS, ACCESSORIES & ESU" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "47 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abscess", "Dyspnea", "Edema", "Nausea", "Perforation", "Renal Failure", "Vomiting", "Ascites" ] } ], "distributor_city": "", "date_report": "20131001", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3440787", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131001", "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": "20710706", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI S TOTAL HYSTERECTOMY, LEFT OVARIAN CYSTECTOMY, LYSIS OF ADHESIONS FOR HISTORY OF WORSENING MENORRHAGIA AND LARGE FIBROID UTERUS ON (B)(6) 2011. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES: THE DISCHARGE SUMMARY FROM HER READMISSION ON (B)(6) 2011, AND DISCHARGE SUMMARY AND THE OPERATIVE REPORT FROM THE FOLLOW ON SURGERY ON (B)(6) 2011 AND THE DISCHARGE SUMMARY HER DRAINAGE ON (B)(6) 2011. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE SURGERY. AFTER A BRIEF DELAY BECAUSE OF CONCERNS ABOUT DIFFICULTY WITH TIDAL VOLUME, THE PROCEDURE PROCEEDED AS PLANNED. USING PROGRASP, PK DISSECTOR AND ENDOSHEARS, THE BROAD LIGAMENTS, UTERINE ARTERIES WERE COAGULATED AND CUT, AND THE UTERUS REMOVED WITH A COLPOTOMY RING AS A BACKSTOP. IT TOOK 20 MINUTES TO FILET THE UTERUS WITH MONOPOLAR SCISSORS TO ALLOW REMOVAL THROUGH THE VAGINA, AND FILMY ADHESIONS TAKEN DOWN IN THE COLIC GUTTERS WITH SHARP AND BLUNT DISSECTION. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. THE PATIENT WAS DISCHARGED THE NEXT DAY IN STABLE CONDITION. ON (B)(6) 2011 THE PATIENT PRESENTED EXTREME SOB, ACUTE RENAL FAILURE, NAUSEA AND VOMITING, AND ELEVATED TROPONINS AND WAS ADMITTED TO ICU FOR SUSPECTED ARDS. CT ON ADMISSION RULED OUT PE AND SHOWED FREE AIR AND ASCITES IN ABDOMEN, NO GUARDING. PATIENT RESPONDED TO BREATHING TREATMENTS, ANTIBIOTICS, IV FLUIDS. DISCHARGED ON (B)(6) 2011 IN STABLE CONDITION ON RESPIRATORY THERAPY AND ANTIBIOTICS WITH RESOLUTION OF TROPONINS AND ELEVATED CREATININE. ON (B)(6) 2011 THE PATIENT WAS ADMITTED AND UNDERWENT AN EMERGENT LAPAROTOMY FOR SUSPECTED PERFORATED VISCUS AND ABDOMINAL WALL ABSCESS AND HISTORY OF FECULENT DRAINAGE FROM RIGHT UPPER QUADRANT DRAIN. AFTER ABDOMINAL EXPLORATION, AND MOBILIZATION OF THE COLON AND DUODENUM, A 5MM PERFORATION WAS LOCATED IN THE ANTIMESENTERIC BORDER OF THE DISTAL ILEUM. IT WAS CLOSED, THE ABDOMEN IRRIGATED AND DEBRIDED OF NECROTIC TISSUE. NO APPARENT COMPLICATIONS WERE NOTED. PATIENT WAS DISCHARGED HOME ON (B)(6) 2011 ON ORAL ANTIBIOTICS. (B)(6) 2011 PATIENT WAS READMITTED FOR ABDOMINAL WALL EDEMA. A SUBDIAPHRAGMATIC PERIHEPATIC ABSCESS WAS IDENTIFIED ON CT, AND AN ULTRASOUND GUIDED DRAINAGE OF 660 CCS OF FLUID PERFORMED. CULTURE RETURNED YEAST. PATIENT DISCHARGED HOME ON DIFLUCAN ON (B)(6) 2011 IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THE DATE OF DISCHARGE ON (B)(6) 2011." }, { "mdr_text_key": "20898950", "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 POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. THE OPERATIVE REPORTS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATED TO THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI SURGICAL 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": "" } ] }