{ "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": "2955842-2021-11861", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20220104", "manufacturer_address_2": "", "pma_pmn_number": "UNKNOWN", "date_of_event": "20210914", "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", "Consumer" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20220105", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "538894", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220104", "brand_name": "DA VINCI", "generic_name": "DA VINCI SURGICAL SYSTEM", "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": "N/A", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "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", "Insufficient Device Problem Information", "Adverse Event Without Identified Device or Use Problem", "Insufficient Device Problem Information" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "12/13/2021", "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": "20220104", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Burn(s)", "Unspecified Tissue Injury", "Burn(s)", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20211213", "initial_report_to_fda": "Yes", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "13160577", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20211213", "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": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "288101926", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ON (B)(6) 2021, INTUITIVE SURGICAL, INC (ISI) RECEIVED FDA VOLUNTARY REPORT #MW5105057 WITH THE FOLLOWING EVENT DESCRIPTION: \"HAD A ROBOTIC RECTOPEXY AT (B)(6) HOSPITAL. UPON DISCHARGE ON (B)(6) 2021 I CHANGED THE DRESSING AT THE OPERATIVE SITE AND NOTICED A ¿HOLE¿ OR POSSIBLE BURNED TISSUE WHICH I REPORTED TO MY PHYSICIAN ON (B)(6) 2021, AND (B)(6) 2021. SINCE HE DID SEE THE WOUNDS POST OP. HE WAS PUZZLED AND HAS REFERRED ME TO THE WOULD CARE CLINIC. I BELIEVE THE HOSPITAL USED THE DA VINCI ROBOTIC SYSTEM AS OF 2013 OR 2014. ALTHOUGH THIS IS A RARE OCCURRENCE (MY PHYSICIAN HAS DONE OVER 400 PROCEDURES), I UNDERSTAND THAT HEAT RELATED INJURIES CAN HAPPEN WHEN SPARKS COME FROM MICROSCOPIC ¿CRACKS¿ THAT MAY / MAY NOT BE SEEN FROM THE CAMERA¿S FIELD OF VISION.\" THE MEDWATCH REPORT WAS LABELED WITH THE \"TYPE OF EVENT\" AS \"SERIOUS INJURY¿ AND \"OUTCOMES ATTRIBUTED TO ADVERSE EVENT\" AS \"REQUIRED INTERVENTION.\" IN ADDITION, THE INITIAL REPORTER (A PATIENT) ELECTED TO NOT BE IDENTIFIED. THEREFORE, NO CONTACT INFORMATION WAS PROVIDED." }, { "mdr_text_key": "288101927", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE CUSTOMER REPORTED POST-OPERATIVE COMPLICATIONS CANNOT BE DETERMINED OR IS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. NO SYSTEM OR INSTRUMENT LOG REVIEW COULD BE PERFORMED DUE TO THE LACK OF SYSTEM AND SITE DETAIL (I.E. UNKNOWN SITE NAME, SURGEON NAME, SYSTEM SERIAL # INFORMATION). NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: PER FDA VOLUNTARY REPORT #MW5105057, A PATIENT UNDERWENT A DA VINCI-ASSISTED RECTOPEXY PROCEDURE AND EXPERIENCED A POST-OPERATIVE COMPLICATION (I.E \"HOLE\" OR POSSIBLE BURNED TISSUE\") THAT REQUIRED MEDICAL INTERVENTION. AT THIS TIME, THE SEVERITY OF THE ALLEGED BURN INJURY, THE MEDICAL INTERVENTION RENDERED DUE TO THE INJURY, AND THE ROOT CAUSE OF THE CUSTOMER REPORTED POST-OPERATIVE COMPLICATION ARE UNKNOWN. BLANK MDR FIELDS: UNABLE TO CONDUCT FOLLOW-UP DUE TO LACK OF SITE DETAIL, THEREFORE THE PATIENT INFORMATION IS UNKNOWN. THE EXPIRATION DATE IS NOT APPLICABLE. MULTIPLE PRODUCT INFORMATION FIELDS ARE UNKNOWN DUE TO LIMITED PRODUCT INFORMATION BEING PROVIDED. BECAUSE PRODUCTS ARE NOT IMPLANTABLE. INFORMATION FOR THE BLANK AND UNKNOWN FIELDS IS NOT AVAILABLE. INSUFFICIENT PRODUCT INFORMATION WAS PROVIDED IN ORDER TO OBTAIN THE 510K NUMBER. INSUFFICIENT PRODUCT INFORMATION WAS PROVIDED IN ORDER TO OBTAIN THE DATE OF MANUFACTURE." }, { "mdr_text_key": "329230264", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "329230265", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE FOLLOWING FIELDS HAVE BEEN UPDATED: B1 AND H6. FIELD B1 - UPDATED FROM ADVERSE EVENT TO ADVERSE EVENT AND PRODUCT PROBLEM DUE TO THE FOLLOWING CONCLUSION: THE ALLEGATION COULD BE RELATED TO THE POTENTIAL FOR ELECTRICAL DISCHARGE AT A LOCATION OTHER THAN INTENDED. FIELD ANNEX A - UPDATED FROM \"A24\" TO \"A26\"." } ], "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": "05/30/2022" } ] }