{ "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": "2955842-2013-03684", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130919", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20121101", "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": "20130919", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "472162", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130919", "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": "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": "20130919", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRMNTS, ACCESSORIES & ESU." ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "36 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Hemorrhage/Blood Loss/Bleeding", "Laceration(s)", "Nausea", "Tissue Damage", "Vomiting" ] } ], "distributor_city": "", "date_report": "20130820", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3358343", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130820", "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": "19017596", "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 MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2012 WITH A PRE-OPERATIVE DIAGNOSIS OF MENOMETRORRHAGIA AND CERVICAL INTRAEPITHELIAL NEOPLASIA III. ACCORDING TO THE PATIENT'S OPERATIVE (OP) REPORT DATED (B)(4) 2012, DURING THE SURGICAL PROCEDURE THE SURGEON ENCOUNTERED MULTIPLE OMENTAL ADHESIONS TO THE ANTERIOR ABDOMINAL WALL AND BLADDER ADHESIONS TO THE ANTERIOR UTERUS, WHICH WERE DISSECTED VERY CAREFULLY. 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 WAS NO INDICATION THAT THE PATIENT EXPERIENCED ANY INTRAOPERATIVE COMPLICATIONS. TOWARDS THE END OF THE PROCEDURE, INDIGO CARMINE WAS INJECTED AND BLUE URINE WAS NOTED, WITHOUT ANY EXTRAVASATION OF DYE IN THE PATIENT'S ABDOMEN. BOTH URETERS WERE THEN OBSERVED THROUGH THE LAPAROSCOPE WITH PERISTALSIS NOTED ON BOTH SIDES. THE PATIENT'S VAGINAL CUFF WAS CLOSED AND UPON COMPLETION OF THE CLOSURE, HEMOSTASIS WAS NOTED. THE PEDICLES WERE ALSO FOUND TO BE HEMOSTATIC. PER THE INFORMATION IN THE OP REPORT, THE PATIENT WAS AWAKENED AND EXTUBATED WITHOUT DIFFICULTY. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON POST-OPERATIVE DAY 1. REPORTEDLY, THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2012 COMPLAINING OF NAUSEA AND VOMITING. THE PATIENT UNDERWENT A RETROGRADE PYELOGRAM GRAM PROCEDURE AND THERE WAS NO EVIDENCE OF OBSTRUCTION OBSERVED; HOWEVER, A STENT WAS PLACED. THE PATIENT TOLERATED THE PROCEDURE AND TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012. THE PATIENT THEN RETURNED TO THE HOSPITAL THE NEXT DAY ON (B)(6) 2012 COMPLAINING OF ABDOMINAL PAIN. ON (B)(6) 2012 THE PATIENT UNDERWENT AN EXPLORATORY PROCEDURE. THE PATIENT WAS FOUND TO HAVE A PENETRATING TRAUMA AND SEROSAL TEAR TO THE SMALL BOWEL. THIS WAS REPAIRED BY RESECTION OF THE SMALL BOWEL WITH PRIMARY ANASTOMOSIS AND REPAIR TO THE SEROSAL TEAR TO THE SMALL BOWEL. POST-OPERATIVELY, THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) WITH BROAD SPECTRUM ANTIBIOTIC THERAPY. ON (B)(6) 2012 THE PATIENT WAS MOVED FROM THE ICU AND ON (B)(6) 2012 THE PATIENT BEGAN TO SHOW IMPROVEMENT IN HER BOWEL FUNCTION. BASED ON THE INFORMATION INDICATED IN THE PATIENT'S MEDICAL RECORDS THE PATIENT'S CONTINUED TO IMPROVE AND ON (B)(6) 2012 THE PATIENT WAS DISCHARGED. BASED ON THE PATIENT'S MEDICAL RECORDS, THE PATIENT'S SUBSEQUENT FOLLOW-UP VISITS SHOWED THAT THE PATIENT CONTINUED TO IMPROVE. REPORTEDLY, DURING A ROUTINE FOLLOW-EXAMINATION ON (B)(6) 2012, THE PATIENT WAS CLEARED TO RESUME NORMAL ACTIVITIES WHICH INCLUDED RETURNING TO WORK AND RESUMING COITUS AND EXERCISING. THE PATIENT'S PROGRESS NOTES INDICATE ON (B)(6) 2013, THE PATIENT RETURNED TO THE HOSPITAL COMPLAINING OF VAGINAL SPOTTING AFTER HAVING INTERCOURSE. THE PATIENT ALSO COMPLAINED OF LEFT UPPER QUADRANT PAIN. AN EXAMINATION FOUND THAT THE PATIENT HAD A 0.5MM SIZE GRANULATION TISSUE IN THE MID VAGINAL CUFF. THE AFFECTED AREA WAS BURNT WITH AG-NITRATE STICKS. THE PATIENT HAD NO ADNEXAL TENDERNESS AND NO MASSES. THE PATIENT WAS REQUESTED TO RETURN IN 1 YEAR." }, { "mdr_text_key": "19062907", "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. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. REVIEW OF THE SITE'S SYSTEM LOGS FOUND THAT THERE WAS NO DA VINCI SURGERY PERFORMED FOR THE REPORTED PROCEDURE DATE OF (B)(6) 2012. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED A BOWEL 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": "" } ] }