{ "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": "2955842-2020-11155", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20201102", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20200916", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "WANG", "source_type": [ "Other", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20201102", "manufacturer_contact_f_name": "DAVID", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1240314", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20201102", "brand_name": "DA VINCI SP", "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": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "380601-34", "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": "00886874114605", "udi_public": "(01)00886874114605", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Insufficient Device Problem Information", "Insufficient Device Problem Information" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "01/21/2021;01/21/2021", "mfr_report_type": "", "manufacturer_contact_country": "US", "date_changed": "20250810", "health_professional": "Y", "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": "20201102", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "46 YR", "patient_sex": "Female", "patient_weight": "113 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "Black Or African American", "patient_problems": [ "Bowel Burn", "Bowel Perforation", "Bowel Burn", "Bowel Perforation" ] } ], "distributor_city": "", "date_report": "20201007", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "10775727", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20201007", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "95051", "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": "329381616", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DUE TO THE SURGEON INDICATING THAT THE COMPLICATION WAS DESCRIBED AS ¿DELAYED THERMAL INJURY THAT PRESENTED 3-WEEKS POST OP,¿ THE COMPLAINT IS BEING RECLASSIFIED AS BOTH AN ADVERSE EVENT AND PRODUCT PROBLEM RATHER THAN JUST AN ADVERSE EVENT AS PREVIOUSLY REPORTED. CORRECTED INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: B1 AND H6 B1 UPDATED FROM \"ADVERSE EVENT\" TO \"ADVERSE EVENT AND PRODUCT PROBLEM\" H6 ANNEX CODES ADDED FOR CODING OF THE REPORTED EVENT." }, { "mdr_text_key": "329381617", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "323121570", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) RECEIVED ADDITIONAL INFORMATION FROM THE CONSOLE SURGEON, AS FOLLOWS: THE PATIENT IS DOING WELL AND HAS RECOVERED FROM THE COMPLICATION, THE PATIENT WAS AN AFRICAN AMERICAN FEMALE WHO HAD THE FOLLOWING ADDITIONAL COMORBIDITY: HYPERTENSION, AND THE SURGEON BELIEVES THAT THERE WAS A ¿DELAYED THERMAL INJURY THAT PRESENTED 3-WEEKS POST OP¿." }, { "mdr_text_key": "216948364", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED OR IS UNKNOWN. HOWEVER, THE HYSTERECTOMY PROCEDURE WAS PERFORMED OFF-LABEL. AT THIS TIME, HYSTERECTOMIES ARE NOT INCLUDED IN THE APPROVED INDICATIONS FOR THE DA VINCI SP SURGICAL SYSTEM. INTUITIVE SURGICAL, INC. (ISI) HAD REACHED OUT TO THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION ABOUT THE PATIENT¿S CURRENT STATUS BUT HAS NOT YET RECEIVED A RESPONSE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. SITE HISTORY REVIEW WAS CONDUCTED ON FOUND NO ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT FOR THIS EVENT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. A REVIEW OF THE SYSTEM AND INSTRUMENT LOGS HAS BEEN PERFORMED. THERE WERE NO OBSERVED EVENTS IN THE SYSTEM LOGS THAT WOULD SUGGEST A PRODUCT ISSUE AND LOGGED EVENTS ARE IN LINE WITH NORMAL SYSTEM FUNCTIONALITY. ADDITIONALLY, ALL INSTRUMENTS USED IN THE CASE WERE USED IN SUBSEQUENT PROCEDURES WITH THE EXCEPTION OF THREE INSTRUMENTS AND A SITE REVIEW SHOWS NO COMPLAINT FILED AGAINST THE INSTRUMENTS. TECHNICAL REVIEW WAS COMPLETED BY AN ISI CLINICAL DEVELOPMENT ENGINEER (CDE) AND FOUND THAT NOTHING WAS OBSERVED FROM A CLINICAL PERSPECTIVE LINKED TO ENERGY ARCING ISSUES. ADDITIONAL TECHNICAL REVIEW BY AN ISI ADVANCED FAILURE ANALYSIS (AFA) ENGINEER FOUND THAT THERE WAS A SINGLE OCCURRENCE OF BIPOLAR ENERGY ¿BEING HALTED¿, BUT IT WAS ONLY A SINGLE OCCURRENCE WHICH CAN HAPPEN FOR A LOT OF REASONS AND ¿DOESN¿T INDICATE ENERGY WITH ENERGY DELIVERY¿. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS REPORTABLE DUE TO THE FOLLOWING: AFTER COMPLETION OF A DA VINCI-ASSISTED TOTAL HYSTERECTOMY PROCEDURE, THE PATIENT DEVELOPED SYMPTOMS ON POST-OPERATIVE DAY #7 OR #8, AND ON POST-OPERATIVE DAY #10 A BOWEL PERFORATION WAS IDENTIFIED VIA OPEN SURGERY. THE BOWEL PERFORATION WAS REPAIRED WITH A RESECTION VIA TWO FOLLOW-UP SURGERIES AND HOSPITALIZATION AT A DIFFERENT SITE. ALTHOUGH THE SURGEON CLAIMED THAT THE BOWEL PERFORATION WAS POSSIBLY CAUSED BY THE THERMAL SPREAD OF AN INSTRUMENT, THE ROOT CAUSE OF THE POST-OPERATIVE COMPLICATION IS UNKNOWN." }, { "mdr_text_key": "216948365", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED TOTAL HYSTERECTOMY PROCEDURE, THE PATIENT WAS FOUND TO HAVE A PERFORATED BOWEL THAT THE SURGEON ALLEGED HAD OCCURRED DURING THE DA VINCI-ASSISTED PROCEDURE. THE SURGEON CONVERTED THE PROCEDURE FROM SINGLE PORT (SP) DA VINCI-ASSISTED PROCEDURE TO A LAPAROSCOPIC PROCEDURE DUE TO DECREASED VISUALIZATION RESULTING FROM A LARGE UTERUS. THE PROCEDURE WAS COMPLETED LAPAROSCOPICALLY. DURING THE CASE, THE SURGEON DID NOT SEE ANY BLEEDING OR STOOL LEAKING. THE PATIENT WAS DISCHARGED HOME. THE PATIENT LATER PRESENTED WITH SYMPTOMS OF A BOWEL PERFORATION BELIEVED TO HAVE BEEN CAUSED BY AN ALLEGED THERMAL INJURY TO THE BOWEL. THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL; IN THE INTENSIVE CARE UNIT (ICU). ON 8-OCT-2020, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE CONSOLE SURGEON: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED TOTAL HYSTERECTOMY PROCEDURE ON (B)(6) 2020, THE PATIENT'S BOWEL WAS INJURED. THE DA VINCI PROCEDURE HAD COMPLETED ROBOTICALLY WITH NO INTRA-OPERATIVE COMPLICATIONS AND NO PATIENT HARM OR INJURY. THE SURGEON DID NOT SEE ANY BLEEDING OR STOOL LEAKING. THE SURGEON STATED THAT A FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS WORKING AS INTENDED AT FIRST WITH TISSUE AFFECT OBSERVED BUT THEN IT STOPPED WORKING, THERE WAS NO ENERGY DELIVERED AND NO VISIBLE TISSUE AFFECT. THERE WAS NO VISIBLE ARCING OR SMOKE; THE INSTRUMENT STOPPED WORKING WITH NO ENERGY DELIVERED. THE ISSUE RESOLVED BY APPLYING AN UNSPECIFIED BACKUP INSTRUMENT; CAUTERY FUNCTION WAS RESTORED. THE PROCEDURE COMPLETED ROBOTICALLY WITH NO PATIENT INJURY. FIVE DAYS POST THE DA VINCI PROCEDURE, THE PATIENT CALLED THE SURGEON WITH REPORTS OF ABDOMINAL PAIN. SEVEN TO EIGHT DAYS LATER, THE PATIENT VISITED THE SURGEON WITH COMPLAINTS OF VOMITING, INFLAMMATION, UNABLE TO PASS GAS, AND ABDOMINAL DISTENSION. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION. A COMPUTERIZED TOMOGRAPHY (CT SCAN) WAS TAKEN AND THE SURGEON STATED RESULTS WERE FINE. TEN DAYS LATER, THERE WAS DRAINAGE FROM THE PATIENT¿S INCISION LINE WITH VISIBLE BOWEL CONTENT WITHIN THE DRAINAGE. AN OPEN SURGERY WAS PERFORMED AND A BOWEL PERFORATION WAS OBSERVED. THE BOWEL WAS REPAIRED BY RESECTING APPROXIMATELY 10CM OF THE SMALL BOWEL. THE OPEN PROCEDURE COMPLETED WITHOUT COMPLICATION AND NO REPORT OF INJURY. FIVE DAYS POST OPEN SURGERY, THE PATIENT HAD ANOTHER OPEN SURGERY TO RE-ANASTOMOSE THE BOWEL WHICH. THE PATIENT WAS STILL IN THE HOSPITAL AS OF (B)(6) 2020, IN THE INTENSIVE CARE UNIT (ICU). ON (B)(6) 2020, IT WAS REPORTED THAT THE PATIENT HAD THE TWO FOLLOW-UP SURGERIES AND HOSPITALIZATION AT (B)(6) HOSPITAL VS (B)(6) HOSPITAL." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "02/15/2021;05/07/2022" } ] }