{ "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": "2955842-2021-11171", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20210922", "manufacturer_address_2": "", "pma_pmn_number": "UNKNOWN", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE", "OTHER" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20210922", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1413769", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210922", "brand_name": "DA VINCI", "generic_name": "PATIENT SIDE CART", "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": "", "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": [ "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": "20250807", "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": "20210922", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Superficial (First Degree) Burn", "Superficial (First Degree) Burn" ] } ], "distributor_city": "", "date_report": "20210829", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "12514521", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210829", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "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": "282004010", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE CUSTOMER REPORTED OPERATIVE COMPLICATION CANNOT BE DETERMINED OR IS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. UNABLE TO CONDUCT SYSTEM OR INSTRUMENT LOG REVIEW DUE TO LACK OF SITE, SYSTEM, PROCEDURE, AND INSTRUMENT DETAIL. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. A CLINICAL JOURNAL ARTICLE CITED THROUGH A RETROSPECTIVE STUDY REVIEW OF ALL PATIENTS UNDERGOING ANY ROBOTIC-ASSISTED ABDOMINAL WALL REPAIR (RAWR) FROM JULY 1, 2016 TO MARCH 18, 2020, THAT A PATIENT ¿SUFFERED A SUPERFICIAL THERMAL INJURY TO THE SIGMOID COLON UPON REDUCTION OF AN INFRAUMBILICAL HERNIA THAT WAS REINFORCED WITH SUTURES AND THE PATIENT WENT ON TO HAVE AN UNEVENTFUL RECOVERY.¿ IT IS UNKNOWN IF THE PATIENT'S COMORBIDITY/COMORBIDITIES OR ANY OTHER PRE-EXISTING CONDITIONS MAY HAVE CONTRIBUTED TO THE ALLEGED EVENTS. WHILE THERE IS INSUFFICIENT INFORMATION PROVIDED TO SUGGEST THAT AN INTUITIVE PRODUCT MALFUNCTIONED, NOR IS THERE ANY CONFIRMED SITE, PROCEDURE, DA VINCI SYSTEM, OR DA VINCI INSTRUMENTATION INFORMATION, THE EVENT MEETS THE CRITERIA OF A REPORTABLE ADVERSE EVENT AS A SUPERFICIAL THERMAL INJURY TO THE SIGMOID COLON WAS ALLEGED WITHIN THE ARTICLE WHICH REQUIRED SUTURES TO ¿REINFORCE¿. AT THIS TIME, THE ROOT CAUSE OF THE ALLEGED ISSUE IS UNKNOWN. FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. MULTIPLE PRODUCT INFORMATION ARE UNKNOWN DUE TO LIMITED PRODUCT INFORMATION BEING PROVIDED. THE PRODUCT IS NOT IMPLANTABLE. IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA." }, { "mdr_text_key": "282004011", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ON 08/29/2021, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A RETROSPECTIVE OBSERVATIONAL STUDY ARTICLE, VIA AN ISI CLINICAL JOURNAL REVIEW, FROM THE ¿JOURNAL OF ROBOTIC SURGERY¿, TITLED, ¿ROBOTIC ABDOMINAL WALL REPAIR: ADOPTION AND EARLY OUTCOMES IN A LARGE ACADEMIC MEDICAL CENTER¿ (PEREIRA, X., LIMA, D. L., ET AL., 2021). WITHIN THE JOURNAL ARTICLE, AN OPERATIVE COMPLICATION INVOLVING A ¿ROBOTIC-ASSISTED¿ PROCEDURE WAS NOTED. THE JOURNAL ARTICLE CITED, IN A ¿RETROSPECTIVE REVIEW OF ALL PATIENTS UNDERGOING ANY RAWR FROM JULY 1, 2016 TO MARCH 18, 2020¿, THAT DURING A ROBOTIC-ASSISTED ABDOMINAL WALL REPAIR (RAWR). THE JOURNAL ARTICLE CITED THAT THIS STUDY WAS CLASSIFIED BY SURGICAL MODALITY AS EITHER OPEN, LAPAROSCOPIC, OR ROBOTIC HERNIA REPAIR, OF 312 PATIENTS INCLUDED IN THE REVIEW, THERE WERE TWO REPORTED INTRAOPERATIVE EVENTS AND NINE OPERATIVE CONVERSIONS. 60 PATIENTS HAD AT LEAST ONE COMPLICATION AT 30 DAYS, AND THERE WAS ONE MAJOR INTRAOPERATIVE EVENT REQUIRING A DEVIATION OF THE PLANNED SURGERY AND PROLONGED ADMISSION. OF THE TWO ¿REPORTABLE INTRAOPERATIVE EVENTS: ONE REQUIRED A CHANGE IN THE INITIAL OPERATIVE PLAN AND HAD A HISTORY OF CIRRHOSIS AND CONTROLLED PORTAL HYPERTENSION WHO SUFFERED A [LAPAROSCOPIC SURGERY INSTRUMENT] VERESS NEEDLE INJURY TO THE LEFT LOBE OF HIS ENLARGED LIVER REQUIRING AN EMERGENT UPPER MIDLINE LAPAROTOMY AND REPAIR OF HEPATIC LACERATION WITH SUBSEQUENT ADMISSION TO THE ICU FOR OBSERVATION. THE SECOND PATIENT ¿SUFFERED A SUPERFICIAL THERMAL INJURY TO THE SIGMOID COLON UPON REDUCTION OF AN INFRAUMBILICAL HERNIA THAT WAS REINFORCED WITH SUTURES AND THE PATIENT WENT ON TO HAVE AN UNEVENTFUL RECOVERY.¿ THE ARTICLE CITES THAT ALL 312 ROBOTIC CASES IN THE STUDY WERE COMPLETED USING EITHER A DA VINCI SI OR XI SYSTEM. HOWEVER, THERE ARE 3 TYPES OF SURGICAL MODALITIES THAT WERE STUDIED: OPEN, ROBOTIC, AND LAPAROSCOPIC. AT THIS TIME, THERE IS NO KNOWN SITE, DA VINCI SYSTEM, OR DA VINCI INSTRUMENTATION INFORMATION AND IT IS UNCONFIRMED AS TO WHETHER A DA VINCI SURGICAL SYSTEM WAS INVOLVED IN THE REPORTED EVENT(S). ISI HAS REACHED OUT TO THE AUTHOR BY PHONE AND BY EMAIL TO OBTAIN ADDITIONAL INFORMATION BUT HAS NOT YET RECEIVED A RESPONSE." } ], "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": "" } ] }