{ "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": "2955842-2014-05070", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20140820", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20140702", "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": "20140820", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "502394", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140820", "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": "", "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": "MI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250724", "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": "20140820", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "60 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Bowel Burn" ] } ], "distributor_city": "", "date_report": "20140721", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4024675", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140721", "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": "16780097", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI NEPHRECTOMY PROCEDURE, THE PATIENT WAS FOUND TO HAVE SUSTAINED A BURN HOLE IN THE BOWEL DURING A RETURN VISIT. THERE WERE NO REPORTS OF AN INCIDENT OCCURRING DURING THE DA VINCI SURGICAL PROCEDURE. THE SITE'S QUALITY DEPARTMENT CLAIMED THAT A FENESTRATED BIPOLAR FORCEPS INSTRUMENT MAY HAVE CAUSED THE PATIENT'S BOWEL INJURY. THE SITE INDICATED THAT DURING THE SURGICAL PROCEDURE, THE ONLY INSTRUMENTS USED WERE A BIPOLAR FORCEPS INSTRUMENT AND A PERMANENT CAUTERY HOOK INSTRUMENT. IN RELATION TO THE REPORTED EVENT, ON 08/14/2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED (B)(4) WITH THE FOLLOWING EVENT DESCRIPTION: THE PATIENT UNDERWENT A ROBOTIC ASSISTED LAPAROSCOPIC RADICAL NEPHRECTOMY, LEFT ADRENALECTOMY, AND REPAIR OF SPLENIC CAPSULAR TEAR. THE PATIENT RETURNED TO THE OPERATIVE ROOM (OR) ONE WEEK LATER FOR EXPLORATORY LAPAROTOMY AND HAS A COLON INJURY. THE OPERATING SURGEON BELIEVES THIS MAY BE A THERMAL BURN FROM THE PRIOR SURGERY; LIKELY FAILURE OF INSULATION ON THE CANNULA. WHAT WAS THE ORIGINAL INTENDED PROCEDURE: (B)(6) 2014 ROBOTIC ASSISTED LAPAROSCOPIC RADICAL NEPHRECTOMY, LEFT ADRENALECTOMY, AND REPAIR OF SPLENIC CAPSULAR TEAR" }, { "mdr_text_key": "17004968", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE AND THE PATIENT'S POST-OPERATIVE COMPLICATION CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. AT THIS TIME, THE LOT OF THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT INVOLVED WITH THIS COMPLAINT IS NOT KNOWN. 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. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI NEPHRECTOMY PROCEDURE, THE PATIENT WAS FOUND TO HAVE SUSTAINED A COLON INJURY. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S INJURY IS UNKNOWN." } ], "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": "" } ] }