{ "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": "I", "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": "2955842-2019-10172", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20190307", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20190124", "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": [ "COMPANY REPRESENTATIVE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20190307", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "194890", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190307", "brand_name": "DA VINCI", "generic_name": "TIP COVER ACCESSORY", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "950 KIFER RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "94086", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "94086", "device_operator": "HEALTH PROFESSIONAL", "model_number": "400180", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "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": [ "Arcing", "Arcing" ], "reporter_state_code": "NC", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/30/2021", "mfr_report_type": "", "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": "20190307", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Injury", "Injury" ] } ], "distributor_city": "", "date_report": "20190207", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8402325", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20190207", "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": "325593798", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE EVENT DATE HAS BEEN CORRECTED FROM 1/23/2019 TO 1/24/2019." }, { "mdr_text_key": "138215640", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE OF THE ALLEGED POST-OPERATIVE COMPLICATION. AS OF THE DATE OF THIS REPORT, ISI HAS NOT RECEIVED THE MCS INSTRUMENT INVOLVED WITH THE REPORTED EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. ISI HAS REVIEWED THE SITE¿S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2019. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI-ASSISTED INGUINAL HERNIA REPAIR PROCEDURE, THE PATIENT RETURNED TO THE HOSPITAL DUE TO INTERNAL BLEEDING AND WAS FOUND TO HAVE A HOLE IN THE SMALL BOWEL. AS A RESULT, THE PATIENT UNDERWENT A SMALL BOWEL RESECTION PROCEDURE. HOWEVER, THE ROOT CAUSE OF THE ALLEGED OPERATIVE COMPLICATION IS UNKNOWN." }, { "mdr_text_key": "138215641", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER UNDERGOING A DA VINCI-ASSISTED INGUINAL HERNIA REPAIR PROCEDURE, THE PATIENT WAS RELEASED AFTER RECOVERY. ON AN UNSPECIFIED DATE POST-OPERATIVELY, THE PATIENT RETURNED TO THE HOSPITAL DUE TO INTERNAL BLEEDING AND UNDERWENT A SMALL BOWEL RESECTION. IT WAS ALLEGED THAT THE OPERATIVE COMPLICATIONS WERE CAUSED BY ¿STRAY ENERGY¿ FROM A MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT. ON (B)(6) 2019, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE¿S OR MANAGER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THERE WERE NO REPORTED ISSUES WITH THE DA VINCI SURGICAL SYSTEM AND NO INTRA-OPERATIVE COMPLICATIONS DURING THE CASE. ON (B)(6) 2019, THE PATIENT RETURNED TO THE HOSPITAL AND WAS FOUND TO HAVE A HOLE IN THE SMALL BOWEL. THE PATIENT UNDERWENT A SMALL BOWEL RESECTION VIA OPEN SURGERY TO ADDRESS THE SMALL BOWEL COMPLICATION. THE'S SITES PATHOLOGY DEPARTMENT ANALYZED THE SPECIMEN AND COULD NOT DETERMINE A CAUSE FOR THE BOWEL COMPLICATION. ACCORDING TO THE ISI CLINICAL SALES REPRESENTATIVE (CSR), THE SURGEON SPECULATED THAT THE BOWEL INJURY WAS A RESULT OF \"CAPACITIVE COUPLING\" FROM THE MCS INSTRUMENT. THE CSR INDICATED THAT THE SITE INSPECTED THE MCS TIP COVER ACCESSORY BEFORE, DURING, AND AFTER THE CASE AND DID NOT FIND ANY ISSUES. THE MCS TIP COVER ACCESSORY IS NOT AVAILABLE FOR RETURN TO ISI FOR EVALUATION. THE SURGICAL STAFF DID NOT ACTUALLY WITNESS AN ARCING EVENT FROM THE MCS INSTRUMENT OR ANY OTHER DEVICES DURING THE CASE. THE CSR MENTIONED THAT A MCS INSTRUMENT, FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT, AND MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT WERE USED DURING THE PROCEDURE. THE CSR DID NOT KNOW WHAT SPECIFIC GENERATOR AND GENERATOR SETTINGS WERE USED DURING THE CASE. THE SITE REPORTEDLY PERFORMED THEIR OWN ONSITE TESTING OF THE MCS INSTRUMENT AND DID NOT FIND ANY ISSUES WITH THE DEVICE. THE MCS INSTRUMENT IS NOT CURRENTLY AVAILABLE FOR RETURN TO ISI SINCE THE DEVICE IS BEING HELD BY THE SITE'S LEGAL DEPARTMENT. THE CSR CONFIRMED THAT THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS PERFORMED ON (B)(6) 2019." } ], "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": "07/16/2021" } ] }