{ "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": "2955842-2014-01366", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20140306", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20121023", "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": "20140307", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "134885", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140306", "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": "SH0601", "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": "OH", "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": "20140306", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "86 YR", "patient_sex": "", "patient_weight": "130", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Bowel Perforation" ] } ], "distributor_city": "", "date_report": "20140218", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3665202", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140218", "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": "11639828", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. ISI CONTACTED THE RISK MANAGEMENT DEPARTMENT ON (B)(4) 2014 AND OBTAINED THE FOLLOWING INFORMATION: THE PATIENT WAS UNDERGOING A DA VINCI ASSISTED LSO PROCEDURE ON (B)(4) 2012. THE ROBOTIC TROCAR AND ENDOSCOPIC SCISSORS WERE INSTALLED ON THE SYSTEM AT THE TIME OF THE PATIENT'S INJURY. THE INJURY WAS REPAIRED USING A GIA-55 STAPLER (NON ISI DEVICE) AND A 3.0 PDS SILK LAMBERT SUTURE. DURING THE SURGERY, THE SURGEON CONVERTED THE PROCEDURE TO OPEN PROCEDURE BECAUSE OF THE PATIENT'S ANATOMICAL ISSUES DUE TO EXTENSIVE ADHESIONS. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED ON (B)(6) 2012. THE PATIENT CAME BACK TO THE HOSPITAL ON AN UNSPECIFIED DATE DUE TO ABDOMINAL PAIN WITH NAUSEA AND VOMITING (VOMITING HAD SOME BILE EMESIS). NO FURTHER CLINICAL INFORMATION WAS PROVIDED ABOUT THE PATIENT'S CONDITION. THE SURGEON FOUND THAT THE DA VINCI SURGICAL SYSTEM WAS EXTREMELY CHALLENGING DUE TO THE EXTENSIVE ADHESIONS ON THE PATIENT. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(4) 2012 AND NO SYSTEM MALFUNCTION WAS FOUND TO HAVE OCCURRED DURING THE REPORTED SURGICAL PROCEDURE. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION:THE PATIENT SUSTAINED INTRAOPERATIVE COMPLICATION DURING A DA VINCI SURGICAL PROCEDURE." }, { "mdr_text_key": "4320641", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(4) 2014, ISI RECEIVED UF/IMPORTER REPORT (B)(4) WITH THE FOLLOWING EVENT DESCRIPTION: WHILE TAKING DOWN ADHESIONS MADE INCIDENTAL HOLE IN SMALL BOWEL, SMALL BOWEL REPAIR DONE." } ], "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": "" } ] }