{ "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": "2955842-2022-14388", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20221005", "manufacturer_address_2": "", "pma_pmn_number": "K191736", "date_of_event": "20220905", "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", "Foreign" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "FR", "manufacturer_contact_area_code": "408", "date_added": "20221005", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20220216", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2247436", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20221005", "brand_name": "DA VINCI", "generic_name": "ENDOSCOPE PLUS", "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": "470057-08", "catalog_number": "470057", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20220909", "device_report_product_code": "GCJ", "device_age_text": "", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "00886874116555", "udi_public": "(01)00886874116555", "openfda": { "device_name": "Laparoscope, General & Plastic Surgery", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Image Orientation Incorrect", "Image Orientation Incorrect" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250731", "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": "20221005", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "71 YR", "patient_sex": "Male", "patient_weight": "87 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Urinary Tract Infection", "Urinary Tract Infection" ] } ], "distributor_city": "", "date_report": "20220905", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "15546670", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220905", "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": "301233836", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY PROCEDURE, THERE WAS AN ORIENTATION ISSUE WITH THE 30-DEGREE ENDOSCOPE 2 HOURS INTO THE PROCEDURE. THE ENDOSCOPE WAS NOT ABLE TO SWITCH BETWEEN UP AND DOWN VIEW AND ONLY ONE ENDOSCOPE WAS AVAILABLE FOR THIS SURGERY. THERE WAS A BEEP EVERY TIME THE SURGEON WANTED TO CHANGE THE SCOPE ORIENTATION. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) DID NOT FIND ANY RELATED ERRORS IN THE LIVE LOGS. PRIOR TO CALLING ISI TECHNICAL SUPPORT, THE CUSTOMER HAD ALREADY DISCONNECTED FROM THE VISION SIDE CART (VSC) AND PATIENT SIDE CART (PSC) AND RESEATED THE ENDOSCOPE. THE TSE ASKED THE CUSTOMER IF THEY HAD ALREADY RESEATED THE STERILE ADAPTER, BUT THE CUSTOMER HAD NOT, AND THEY DID NOT WANT TO DO SO AS THE SURGERY WAS IN PROGRESS. NO MECHANICAL SOUND WAS PRESENT FROM THE ENDOSCOPE WHEN THE 30 DEGREE UP/DOWN BUTTON WAS PRESSED. THE CUSTOMER DECIDED TO CONTINUE THE PROCEDURE AS IS. ISI FOLLOWED UP WITH THE INITIAL REPORTER (SURGEON) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON INDICATED THAT THE PROBLEM AROSE AT THE TIME OF PERFORMING A RETRO-BLADDER ANASTOMOSIS ON A PROSTATECTOMY. THE SURGEON EXPLAINED THAT THE EVENT DID NOT OCCUR DURING A WARM ISCHEMIA TIME, BUT IN A TIME WITH UNSPECIFIED \"IMPORTANT FUNCTIONAL ISSUES.\" THE SURGEON INDICATED THERE WAS A LOT OF TIME THAT WAS LOST (45 TO 60 MINUTES) BECAUSE IT WAS AN ANASTOMOSIS IN A CONTEXT OF PRESERVATION OF THE PELVIC FASCIA, IN WHICH THE SURGEON NEEDED TO BE ABLE TO TILT THE OPTICS TO PLACE THE SUTURES. THE ENDOSCOPE'S IMAGE AND SURGEON CONTROLS WERE NOT INVERTED DURING THE PROCEDURE, NOR DID THE ENDOSCOPE MOVE IN THE OPPOSITE DIRECTION TO THE SURGEON'S COMMANDS. THE PATIENT WAS INITIALLY DISCHARGED ON POST-OPERATIVE DAY (POD) 2 BUT WAS RE-HOSPITALIZED ON POD #7 UNTIL DAY 10 DUE TO A NOSOCOMIAL POSTOPERATIVE URINARY TRACT INFECTION WHICH CAN BE LINKED TO THE INCREASED OPERATING TIME. THE URINE CULTURES GREW E. COLI. (THE PRE-OPERATIVE URINE CULTURE WAS STERILE). THERE WAS NO CHANGE IN THE SITE'S CLEANING OR STERILIZATION METHODS RECENTLY." }, { "mdr_text_key": "301233837", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE PATIENT¿S POST-OPERATIVE COMPLICATION CAN BE POSSIBLY ATTRIBUTED TO THE PROCEDURE DELAY SECONDARY TO THE REPORTED ENDOSCOPE ISSUE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE 30 DEGREE ENDOSCOPE PLUS INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE ENDOSCOPE WAS FOUND TO HAVE SCOPE BEARING FRICTION. THE ROOT CAUSE OF THIS FAILURE IS DUE TO MISHANDLING/MISUSE. ADDITIONAL FINDINGS THAT WERE NOT REPORTED BY THE SITE: THE ENDOSCOPE WAS FOUND TO HAVE DISTAL TIP MECHANICAL DAMAGE. THE ROOT CAUSE OF THIS FAILURE IS DUE TO MISHANDLING/MISUSE. FAILURE ANALYSIS ALSO NOTED THAT THE ENDOSCOPE FAILED FUNCTIONAL TESTING; THE LEFT EYE DID NOT PASS THE FOCUS TEST. THE ROOT CAUSE OF THIS FAILURE WAS NOT DETERMINABLE/APPLICABLE. A REVIEW OF THE SYSTEM AND INSTRUMENT LOGS HAS BEEN PERFORMED. THERE WERE NO OBSERVED EVENTS IN THE AVAILABLE SYSTEM LOGS THAT WOULD SUGGEST A PRODUCT ISSUE, AND LOGGED EVENTS ARE IN LINE WITH NORMAL SYSTEM FUNCTIONALITY. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY PROCEDURE, THERE WAS AN ORIENTATION ISSUE OF THE ENDOSCOPE WHICH LED TO A PROCEDURE DELAY OF 45-60 MINUTES. POST-OPERATIVELY, THE PATIENT SUFFERED A UTI ON POD #7 AND WAS RE-HOSPITALIZED. THE SURGEON BELIEVES THAT THE UTI WAS CONTRIBUTED BY THE PROLONGED PROCEDURE TIME." } ], "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": "" } ] }