{ "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": "2026-09-22", "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": "2955842-2013-03491", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130912", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20110425", "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": "20130912", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "460163", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130912", "brand_name": "DA VINCI SI 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": "SI 3000 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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250813", "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": "20130912", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "52 YR", "patient_sex": "", "patient_weight": "144", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Pain", "Pulmonary Edema", "Respiratory Failure", "No Code Available" ] } ], "distributor_city": "", "date_report": "20130816", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3344646", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130816", "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": "3814568", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT, INTUITIVE SURGICAL, INC., (ISI) RECEIVED INFORMATION AND THE MEDICAL RECORDS OF A PATIENT WHO PLANNED FOR ROBOTIC ASSISTED HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY ,BUT WAS CONVERTED TO LAPAROTOMY DUE TO INTRA-OPERATIVE COMPLICATION. THE PATIENT WAS ADMITTED IN THE HOSPITAL ON (B)(6) 2011 FOR ENDOMETRIAL HYPERPLASIA. DURING THE TOTAL HYSTERECTOMY PROCEDURE ON (B)(6) 2011, THE 8MM TROCAR WAS PLACED IN THE ABDOMEN BUT ITS TIP COULD NOT BE IDENTIFIED. AFTER FURTHER EVALUATION, THE TROCAR WAS PLACED THROUGH THE ADHESIONS ON THE SCAR THAT THE PATIENT ACQUIRED FROM THE PREVIOUS CHOLECYSTECTOMY. THE SURGEON PULLED RIGHT SIDED 8MM TROCAR. AT THE EVALUATION OF THE TROCAR, SURGEON NOTICED MATERIAL ON ITS TIP RESEMBLING STOOL. THE DECISION WAS TO PROCEED WITH A LAPAROTOMY. THE PATIENT HAD BEEN OOZING MORE THAN TYPICAL,DUE TO THE PATIENT BEING ON PLAVIX. THE PATIENT'S BOWEL WAS PACKED CEPHALAD WITH MOIST LAPAROTOMY SPONGES. THE PATIENT'S INJURY WAS REPAIRED. THE PATIENT TOLERATED THE PROCEDURE WELL. POST-OPERATIVELY, THE PATIENT HAD MENORRHAGIA REQUIRING MULTIPLE BLOOD TRANSFUSIONS AND SUBSEQUENTLY BECAME HYPOTOXOIC. THE PATIENT HAD A CHEST X-RAY PERFORMED WHICH DID SHOW PULMONARY EDEMA AND CARDIOMEGALY. THE PATIENT HAD RESPIRATORY FAILURE AND IS MORBIDLY OBESE. THE PATIENT ALSO HAD A TRACHEOSTOMY TUBE IN PLACE. THE PATIENT WAS DISCHARGED ON (B)(6) 2011 AND HAD BEEN IN THE HOSPITAL SINCE (B)(6) 2011 FOR OTHER HEALTH CONDITIONS INCLUDING RESPIRATORY FAILURE AND PROLONGED INTUBATION. NO FURTHER CLINICAL INFORMATION REGARDING THE PATIENT'S CONDITION HAS BEEN PROVIDED SINCE HER DISCHARGE DATE OF (B)(6) 2011." }, { "mdr_text_key": "11288979", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF THE POST- SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT, 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. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2011 AND NO MALFUNCTION WAS FOUND TO HAVE OCCURRED DURING THE REPORTED SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE OPERATIVE REPORT INDICATED THAT AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE THE PATIENT SUFFERED TRANSVERSE COLON INJURY." } ], "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": "" } ] }