{ "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": "2955842-2013-04033", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20131004", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120301", "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": "20131007", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "503873", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131004", "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": "DA", "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": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250818", "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": "20131004", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "35 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Perforation", "Injury", "Burn, Thermal" ] } ], "distributor_city": "", "date_report": "20131004", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3388819", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131004", "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": "11343649", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(4) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED THE OPERATIVE REPORT FROM THE ATTORNEY REPRESENTING THE PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY WITH EXTENSIVE LYSIS OF ADHESIONS WHICH HAD TO BE CONVERTED TO AN ABDOMINAL HYSTERECTOMY ON (B)(6) 2012. THE PATIENT'S PRE-OPERATIVE DIAGNOSIS WAS DYSFUNCTIONAL UTERINE BLEEDING, DYSMENORRHEA, AND AN ENLARGED FIBROID UTERUS. BASED ON THE OPERATIVE REPORT, THERE WAS NO INDICATION THAT A MALFUNCTION OF THE DA VINCI SI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. ACCORDING TO THE OPERATIVE REPORT, INITIAL EXAMINATION NOTED ADHESIONS OF THE OMENTUM FROM THE UMBILICUS TO THE FUNDUS. THE UTERUS WAS FOUND TO BE COMPLETELY ADHERED TO THE ANTERIOR ABDOMINAL WALL FROM THE FUNDUS DOWN TO THE LOWER UTERINE SEGMENT. THE SURGEON NOTED THAT AFTER THE OMENTAL ADHESIONS WERE TAKEN DOWN WITH MONOPOLAR CAUTERY AND SHARP DISSECTION, THE ROBOT WAS ENGAGED FOR FURTHER ADHESIOLYSIS. BEFORE TAKING DOWN THE ENTIRE EXTENT OF THE ADHESIONS, THE SURGEON MADE THE DECISION TO DISSECT THE LATERAL ASPECT OF THE UTERUS. THE URETERS WERE IDENTIFIED BILATERALLY AND THE RIGHT TUBE WAS CAUTERIZED AND TRANSECTED. LEFT-SIDED ADHESIOLYSIS WAS ALSO PERFORMED DOWN TO THE LEVEL OF THE UTERINE ARTERIES IN ADDITION TO DISSECTION OF THE SPACE BETWEEN THE BLADDER AND UTERUS. DURING DISSECTION OF THE BLADDER, THE SURGEON NOTED THAT BLEEDING WAS ENCOUNTERED. THE BLEEDING WAS INITIALLY CONTROLLED WITH BOVIE CAUTERY. HOWEVER, THE SURGEON NOTED THAT VISUALIZATION OF PNEUMOPERITONEUM WAS THEN LOST. ATTEMPTS TO FIX THE LOSS OF PNEUMOPERITONEUM WITH REPLACEMENT OF THE TUBE FOR REPLACEMENT OF CO2 WERE UNSUCCESSFUL. THERE WAS NO GAS IN THE FOLEY CATHETER BAG WHICH IS A CLINICAL SIGN THAT THE BLADDER WAS NOT PERFORATED. DUE TO PERSISTENT OOZING AND THE LACK OF PNEUMOPERITONEUM WHICH CAUSED OBSCURING OF THE OPERATIVE FIELD, THE SURGEON MADE THE DECISION TO CONVERT TO OPEN SURGICAL TECHNIQUES. AFTER THE ROBOT WAS DISENGAGED AND THE TROCARS WERE REMOVED, THE SURGEON PROCEEDED TO CONTINUE THE PROCEDURE UTILIZING OPEN SURGICAL TECHNIQUES. DURING THE OPEN PROCEDURE, A SELF-RETAINING RETRACTOR WAS PLACED AND THE UTERUS WAS ELEVATED. ACCORDING TO THE SURGEON, OOZING WAS OBSERVED BUT NO OBVIOUSLY BLEEDING WAS FOUND. AFTER THE CERVIX WAS CLOSED WITH SUTURES, THE OPERATIVE SITE WAS IRRIGATED AND CLEARED OF ALL CLOTS AND DEBRIS. AT THAT POINT, BLEEDING WAS NOTED FROM THE CUFF WHICH WAS THEN CONTROLLED WITH SEVERAL MORE FIGURE-OF-EIGHT SUTURES. DURING IRRIGATION AND INSPECTION OF THE RECTUS MUSCLES, BLEEDING WAS OBSERVED AND CONTROLLED WITH 2 FIGURE-OF EIGHT SUTURES. ACCORDING TO THE SURGEON, THE PATIENT TOLERATED THE PROCEDURE WELL. NO ADDITIONAL INFORMATION WAS PROVIDED POST-OPERATIVELY." }, { "mdr_text_key": "18256685", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON SEPTEMBER 5, 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION FROM AN ATTORNEY REPRESENTING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2012, ALLEGING INJURIES INCLUDING A THERMAL BURN TO THE ABDOMINAL AREA LEADING TO PERFORATION IN THE PELVIC AREA. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME." }, { "mdr_text_key": "18433826", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE LIMITED INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATION(S) EXPERIENCED BY THE PATIENT. THE INFORMATION RECEIVED DOES NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. 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. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: A PATIENT'S ATTORNEY ALLEGED A THERMAL BURN TO THE ABDOMINAL AREA LEADING TO PERFORATION IN THE PELVIC AREA 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": "10/31/2013" } ] }