{ "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": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SANTA CLARA", "manufacturer_contact_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_contact_pcity": "40852321", "event_type": "Injury", "report_number": "2955842-2022-12412", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20220625", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20220527", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20220625", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "634895", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220625", "brand_name": "DA VINCI", "generic_name": "TIP COVER ACCESSORY", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_d_address_2": "", "manufacturer_d_city": "SANTA CLARA", "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": "400180-14", "catalog_number": "400180", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "R", "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": [ "Adverse Event Without Identified Device or Use Problem", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250803", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "4085", "patient": [ { "patient_sequence_number": "1", "date_received": "20220625", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Bowel Burn", "Bowel Burn" ] } ], "distributor_city": "", "date_report": "20220527", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "14812810", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220527", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "INTUITIVE SURGICAL, INC", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "295108329", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INCISIONAL HERNIA REPAIR PROCEDURE WITH INTRAPERITONEAL ONLAY MESH (IPOM), THE SURGEON WAS HOLDING THE SMALL BOWEL WITH A CADIERE FORCEPS INSTRUMENT WHEN HE ACTIVATED THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT ON THE RIGHT ARM. AT THAT TIME, IT WAS NOTICED THAT THE SMALL BOWEL IN THE JAWS OF THE CADIERE FORCEPS INSTRUMENT HAD CHANGED COLOR AND WAS BURNED. AS A RESULT, THE SURGEON HAD TO PLACE SUTURES ON THE SMALL BOWEL TO ADDRESS THE BURN. ALTHOUGH THERE WAS NO ARCING OBSERVED FROM THE MCS INSTRUMENT, IT IS UNKNOWN WHAT CAUSED THE BOWEL BURN. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION: THE SURGEON STATED HE HAD THE CADIERE FORCEPS INSTRUMENT INSTALLED ON THE LEFT ARM AND THE MCS INSTRUMENT INSTALLED ON THE RIGHT ARM. THE SURGEON WAS HOLDING THE SMALL BOWEL WITH THE CADIERE FORCEPS INSTRUMENT. THE SURGEON ACTIVATED THE MCS INSTRUMENT ON THE RIGHT ARM. AT THAT TIME, THE SURGEON NOTICED THE SMALL BOWEL IN THE JAWS OF THE CADIERE FORCEPS INSTRUMENT HAD CHANGED COLOR AND WAS BLANCHED (AS AN IMPRINT OF THE INSTRUMENT JAWS ON THE SMALL BOWEL). AS A RESULT, THE SURGEON HAD TO PLACE SUTURES ON THE SMALL BOWEL TO ADDRESS THE THERMAL BURN. IT WAS CONFIRMED THAT THERE WAS NO ARCING WITNESSED AND INSTRUMENTS WERE NOT CLOSE TO EACH OTHER. THE INSTRUMENTS WERE ALSO NOT SUBMERGED IN FLUIDS. THE MCS INSTRUMENT WAS REMOVED, AND THE MCS TIP COVER ACCESSORY WAS EXAMINED. IT WAS CONFIRMED THERE WAS NO TEAR OR HOLES IN THE MCS TIP COVER ACCESSORY. THE SURGEON WAS DONE WITH USING THE MCS INSTRUMENT AND CONTINUED WITH A NEEDLE DRIVER INSTRUMENT. THE SURGEON CONFIRMED THERE WAS NO ISSUE WITH THE GROUNDING PAD PLACEMENT OR THE SETTINGS OF THE GENERATOR. THE TIPS OF THE MCS INSTRUMENT AND THE CADIERE FORCEPS WERE ABOUT TWO CENTIMETERS APART. THE TISSUE THAT THE SURGEON WAS ENERGIZING WITH THE MCS INSTRUMENT WAS NOT CAUTERIZED. THE MCS INSTRUMENT WAS INSERTED WITH A 12MM CANNULA AND A REDUCER, WHILE THE CADIERE INSTRUMENT WAS INSERTED IN AN 8 MM CANNULA. THE SURGEON BELIEVES ALL THE CABLES OUTSIDE MAY HAVE BEEN ENTANGLED; HOWEVER, HE COULD NOT CONFIRM. THE SURGEON IS UNSURE IF ANY INSTRUMENTS WILL BE RETURNED TO ISI FOR EVALUATION." }, { "mdr_text_key": "295108330", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CAN BE POTENTIALLY CAUSED BY DIRECT COUPLING. DIRECT COUPLING OCCURS WHEN THE ELECTROSURGICAL UNIT IS ACCIDENTALLY ACTIVATED WHILE THE ACTIVE ELECTRODE IS IN CLOSE PROXIMITY TO ANOTHER METAL INSTRUMENT E.G. LAPAROSCOPE, METAL GRASPER FORCEPS, WITHIN THE ABDOMEN. CURRENT FROM THE ACTIVE ELECTRODE FLOWS THROUGH THE SECONDARY INSTRUMENT THROUGH THE PATHWAY OF LEAST RESISTANCE, AND POTENTIALLY DAMAGES ADJACENT STRUCTURES OR ORGANS IN DIRECT CONTACT WITH THE SECONDARY INSTRUMENT. DIRECT COUPLING CAN BE PREVENTED WITH VISUALIZATION OF THE ELECTRODE IN CONTACT WITH THE TARGET TISSUE AND AVOIDING CONTACT WITH ANY OTHER CONDUCTIVE INSTRUMENTS PRIOR TO ACTIVATING THE ELECTRODE. IT WAS CONFIRMED THAT THE MCS TIP COVER ACCESSORY HAS BEEN DISCARDED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS PERFORMED. INVESTIGATION REVEALED THERE WERE NO RELATED INSTRUMENT ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. ADDITIONALLY, BOTH THE MCS INSTRUMENT AND THE CADIERE FORCEPS INSTRUMENT HAVE BEEN USED IN A SUBSEQUENT PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED INCISIONAL HERNIA REPAIR PROCEDURE WITH IPOM, A THERMAL BURN INJURY TO THE SMALL BOWEL OCCURRED WHILE THE SURGEON WAS HOLDING THE SMALL BOWEL WITH A CADIERE FORCEPS INSTRUMENT INSTALLED ON THE LEFT ARM AND ACTIVATING THE MCS INSTRUMENT ON THE RIGHT ARM. AS A RESULT, THE SURGEON HAD TO PLACE SUTURES ON THE SMALL BOWEL TO ADDRESS THE BURN. ALTHOUGH THERE WAS NO ARCING OBSERVED FROM THE MCS INSTRUMENT, IT IS UNCLEAR IF AN ARCING EVENT OCCURRED AND THE CAUSE OF THE BOWEL BURN IS UNKNOWN." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }