{ "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": "2955842-2013-04867", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131101", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130415", "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": "563344", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131101", "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": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "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": "20131101", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS, ACCESSORIES & ESU" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "43 YR", "patient_sex": "", "patient_weight": "68", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pulmonary Embolism", "Abdominal Pain", "Abscess", "Chest Pain", "Purulent Discharge", "Pain", "Thrombosis", "Discomfort", "Bowel Perforation", "Test Result" ] } ], "distributor_city": "", "date_report": "20131002", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3442645", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131002", "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": "16552943", "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 SI TOTAL HYSTERECTOMY FOR MENORRHAGIA WITH ENLARGED FIBROID UTERUS GREATER THAN 250G ON (B)(6) 2013. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. MULTIPLE LABORATORY AND RADIOLOGIC FINDINGS WERE PROVIDED AS WELL AS NARRATIVES FROM POST-OPERATIVE VISITS TO PCPS AND SUBSEQUENT HOSPITAL VISITS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. THE UTERUS WAS NOTED TO BE VERY LARGE, AND MOBILE. BOTH URETERS WERE VISUALIZED AND PERISTALSING NORMALLY. INDIGO CARMINE WAS ADMINISTERED AND FLOW FROM URETERS WAS VISUALIZED. BLOOD LOSS WAS APPROXIMATELY 100ML. THE PATIENT WAS AWAKENED AND TAKEN TO THE RECOVERY ROOM, HAVING TOLERATED THE PROCEDURE WELL. DATE OF DISCHARGE NOT SPECIFIED. THE PATIENT WAS ADMITTED ON (B)(6) 2013 AFTER PRESENTING TO THE ER WITH INCREASING PAIN AND DISCOMFORT. A CT SCAN SHOWED FLUID IN THE PELVIS LEADING TO POTENTIAL CONCERN FOR POSSIBLE PERFORATION. RECTAL CONTRAST CONFIRMED A LEAK. ON (B)(6) 2013, A LAPAROTOMY WAS PERFORMED FOR RECTOSIGMOID RESECTION WITH END COLOSTOMY. NON-PURULENT LUID WAS ENCOUNTERED AND WAS SENT FOR CULTURE. A 2CM PERFORATION OF THE RECTUM WAS IDENTIFIED ABOVE THE VAGINAL CUFF. THE PROXIMAL SIGMOID COLON WAS DIVIDED WITH A STAPLER AND A LIGASURE WAS USED TO DIVIDE THE MESENTERY DOWN TOWARDS THE PERFORATION. AN OSTOMY WAS COMPLETED AND THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. A SURGICAL PATHOLOGY REPORT NOTED A 1CM TRANSMURAL PERFORATION. ON (B)(6) 2013, THE PATIENT PRESENTED WITH ABDOMINAL & CHEST PAIN WITH SHORTNESS OF BREATH AND WAS EVALUATED FOR PULMONARY EMBOLISM. WHITE BLOOD CELL COUNTS HAD INCREASED. AN ACUTE RIGHT LOWER LOBE PULMONARY EMBOLISM WAS CONFIRMED. MULTIPLE FLUID COLLECTIONS IN THE ABDOMEN AND PELVIS WERE PRESENT. MILD RIGHT HYDROURETER WITHOUT HYDRONEPHROSIS WAS DIAGNOSED. ON (B)(6), A PICC LINE WAS INSERTED FOR A LEFT OVARIAN VEIN THROMBOSIS AND A CT GUIDED DRAINAGE OF PELVIC ABSCESS / ABDOMINAL FLUID COLLECTION WAS PERFORMED. THE CATHETER WAS LEFT IN. A CT SCAN WAS REPEATED ON (B)(6) 2013 TO VERIFY CATHETER LOCATION AND IT WAS REPOSITIONED. OVER 150CC OR PURULENT MATERIAL WAS REMOVED. ON (B)(6) 2013, AN ULTRASOUND GUIDED ACCESS TO THE RIGHT COMMON FEMORAL VEIN FOR AN INFERIOR VENACAVOGRAM AND PLACEMENT OF AN INFERIOR VENA CAVA TULIP ICV FILTER WAS PLACED. ON (B)(6), THE CATHETER WAS REPOSITIONED UNDER FLUOROSCOPIC GUIDANCE. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2013 WITH THE PELVIC DRAIN IN PLACE. ON (B)(6) 2013, A DRAINAGE CATHETER HECK WAS PERFORMED WITH CT AND THE CATHETER REPOSITIONED. THE CATHETER WAS REMOVED DURING AN ABSCESSOGRAM PROCEDURE ON (B)(6) 2013. ON (B)(6) 2013, REMOVAL OF THE VENA CAVA FILTER WAS PERFORMED. ON (B)(6) 2013, SHE PRESENTED WITH COMPLAINT OF PAIN AT HER OSTOMY SITE. IT WAS NOTED THAT HER INCISION HAD HEALED PROPERLY AND MILD TENDERNESS WAS PRESET AT THE SITE, BUT IT WAS FUNCTIONING WELL. DURING THE MONTH OF AUGUST SHE RETURNED FOR FOLLOWUP VISITS AND HER VAGINAL DISCHARGE WAS LESSENING WITH ANTIBIOTIC TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER (B)(6) 2013" }, { "mdr_text_key": "16708577", "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. 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 SUSTAINED A UTERER INJURY DURING 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": "" } ] }