{ "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": "2955842-2015-00105", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20150116", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20150107", "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", "Foreign" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20150120", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "39569", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20150116", "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": "IS3000 A6.0P8", "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": [ "Break", "Device Operates Differently Than Expected" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250808", "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": "20150116", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Partial thickness (Second Degree) Burn" ] } ], "distributor_city": "", "date_report": "20150109", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4428931", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20150120", "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": "18537207", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS RETURNED AND EVALUATED, AND NO FAILURE MODES WERE FOUND THAT WOULD HAVE LIKELY CAUSED/CONTRIBUTED TO THE REPORTED PORT INCISION BURNS. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY AND CAUTERY TESTING. THE DEVICE EVALUATION OF THE INSTRUMENT HAS BEEN INITIALLY SUBMITTED VIA MFR REPORT 2955842-2015-00157. THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE, THE PATIENT WAS FOUND TO HAVE SUSTAINED SMALL BURNS AROUND 2 PORT INCISION SITES. THE BURNED TISSUE WAS CUT OFF PRIOR TO SUTURING. HOWEVER, AT THIS TIME, IT IS STILL UNCLEAR IF THE PATIENT ACTUALLY SUSTAINED BURNS AND THE CAUSE OF THE PORT SITE INJURIES IS UNKNOWN." }, { "mdr_text_key": "15905370", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY, THE PATIENT WAS FOUND TO HAVE POST-OPERATIVE SMALL BURNS LOCATED ON BOTH 8MM TROCAR INCISION SITES. ACCORDING TO THE INITIAL REPORTER, THE BURNED TISSUE WAS CUT OUT BEFORE SUTURING WAS PERFORMED. ON (B)(4) 2015, INTUITIVE SURGICAL, INC. (ISI) RECEIVED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE INITIAL REPORTER. NO PICTURES OR PHOTOS OF THE PORT SITE BURNS WERE AVAILABLE FOR REVIEW. ACCORDING TO THE INITIAL REPORTER, THE BURNED TISSUE APPEARED BLACK IN COLOR AND COMPLETELY SURROUNDED EACH PORT SITE AS A 1 MM RING. THE INITIAL REPORTER ALSO DESCRIBED THE BURNED TISSUE AS BEING SECOND DEGREE BURNS. THE BURNED TISSUE WAS CUT OUT PRIOR TO SUTURING BUT NO TISSUE SAMPLES WERE OBTAINED FOR ANALYSIS. THE INSTRUMENTS INSTALLED AT EACH PORT INVOLVED WITH THE PORT SITE BURNS WERE AN UNSPECIFIED BIPOLAR CLAMP INSTRUMENT AND AN UNSPECIFIED SCISSOR INSTRUMENT. NO ISSUES OR EVIDENCE OF ARCING WERE OBSERVED WITH EACH INSTRUMENT DURING THE PROCEDURE. THE GROUNDING PAD WAS INSTALLED ON THE PATIENT'S LEG AND NO ISSUES WERE OBSERVED WITH THE PAD. AN ERBE ELECTROSURGICAL UNIT (ESU) WAS UTILIZED DURING THE PROCEDURE BUT THE SETTINGS WERE NOT PROVIDED. NO POST-OPERATIVE COMPLICATIONS HAVE BEEN REPORTED AND ACCORDING TO THE INITIAL REPORTER, THE PATIENT WAS DOING FINE. DURING THE DA VINCI SURGICAL PROCEDURE, THE SURGICAL STAFF INDICATED THAT A FENESTRATED BIPOLAR FORCEPS WAS NOT WORKING PROPERLY. UPON INSPECTION OF THE INSTRUMENT, THE SURGICAL STAFF INDICATED THAT THE INSTRUMENT WAS BROKEN BUT NO MISSING FRAGMENTS WERE OBSERVED." }, { "mdr_text_key": "16020564", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT INVOLVED WITH THIS COMPLAINT HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE, THE PATIENT WAS FOUND TO HAVE SUSTAINED SMALL BURNS AROUND 2 PORT INCISION SITES. THE BURNED TISSUE WAS CUT OFF PRIOR TO SUTURING. HOWEVER, AT THIS TIME, IT IS UNCLEAR IF THE PATIENT ACTUALLY SUSTAINED BURNS AND THE CAUSE OF THE PORT SITE INJURIES 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": "01/30/2015" } ] }