{ "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": "2955842-2013-04905", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131101", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20110114", "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": "20131104", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "562766", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131101", "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": "20250826", "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 AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "38 YR", "patient_sex": "", "patient_weight": "64", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Abscess", "Edema", "Fever", "Inflammation", "Swelling", "Hernia" ] } ], "distributor_city": "", "date_report": "20131002", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3444103", "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": "3788683", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI S TOTAL HYSTERECTOMY AND DRAINAGE OF LEFT OVARIAN CYST FOR SEVERE MENORRHAGIA, SEVERE DYSMENORRHEA, AND FAILED ENDOMETRIAL ABLATION ON (B)(6) 2008. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT FOR THE PRIMARY PROCEDURE, THE EMERGENT LAPAROTOMY AND THE LAPAROSCOPIC HERNIOPLASTY. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THE PORTS WERE PLACED, AND AFTER INCISION AND DRAINAGE OF THE LEFT OVARIAN CYST, THE OVARIAN SUSPENSORY LIGAMENTS, PROXIMAL BROAD LIGAMENTS AND ROUND LIGAMENTS WERE SERIALLY CLAMPED, CAUTERIZED AND TRANSECTED. THE BLADDER FLAP WAS DEVELOPED, THE CARDINAL LIGAMENTS AND UTERINE VESSELS SEALED AND TRANSECTED, AND THE COLPOTOMY PERFORMED AGAIN THE COLPOTOMY RING. THE UTERUS WAS DELIVERED THROUGH THE VAGINA AND THE VAGINAL CUFF CLOSED WITH V-LOC SUTURE. SEPRAFILM SLURRY WAS PLACED OVER THE VAGINAL DOME TO TRY TO PREVENT ADHESION FORMATION, AND THE SURGERY COMPLETED WITHOUT COMPLICATION. ON (B)(6) 2011 PATIENT PRESENTED WITH RLQ AND FEVER. CT IMAGING SHOWED INFLAMMATORY CHANGES IN THE PELVIS WITH BOWEL WALL THICKENING AND EDEMA AND A PELVIC FLUID COLLECTION THAT APPEARED TO BE AN ABSCESS. ON (B)(6) 2011 PATIENT UNDERWENT AN EMERGENCY LAPAROTOMY WITH DRAINAGE OF PELVIC ABSCESS, ADHESIOLYSES AND APPENDECTOMY FOR ACUTE ABDOMEN, PELVIC ABSCESS AND BOWEL OBSTRUCTION. THE PATIENT'S ABDOMEN WAS NOTABLE FOR LEVEL OF PERITONITIS, ADHESIONS, OMENTAL CAKING AND SIGNS OF THERMAL EXPOSURE ON THE PELVIC FLOOR FROM THE PREVIOUS SURGERY. AN INCIDENTAL APPENDECTOMY WAS PERFORMED. ON (B)(6) 2011 IN A FOLLOW UP VISIT PATIENT WAS DOING WELL WITH HEALING OF THE ABDOMINAL WOUND. ON (B)(6) 2011 PATIENT UNDERWENT LAPAROSCOPIC ADHESIOLYSIS, VENTRAL HERNIOPLASTY WITH MESH AND LEFT SALPINGO-OOPHORECTOMY FOR VENTRAL HERNIA AND LEFT OVARIAN CYSTIC MASS. THE ADHESIOLYSIS AND SALPINGO-OOPHORECTOMY WERE COMPLETED, AND THE VENTRAL HERNIA REPAIRED WITH MESH FIXED WITH ABSORBABLE TACKS. ON (B)(6) 2013 PATIENT PRESENTED WITH A NEW ONSET REDUCIBLE EPIGASTRIC INCISIONAL HERNIA AND RLQ ABDOMINAL PAIN. PATIENT DECLINED TO GET CT SCAN BECAUSE OF COPAY, BUT INDICATED SYMPTOMS WERE IMPROVING. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THE POST OPERATIVE VISIT." }, { "mdr_text_key": "11375233", "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 FOR THE POST-OPERATIVE COMPLICATION(S) EXPERIENCED BY THE PATIENT. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT SUSTAINED POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI S 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": "" } ] }