{ "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": "2955842-2022-16308", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20230106", "manufacturer_address_2": "", "pma_pmn_number": "K191736", "date_of_event": "20221207", "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", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20230106", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20211207", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "634449", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230106", "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": "No", "device_report_product_code": "GCJ", "device_age_text": "", "device_evaluated_by_manufacturer": "R", "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", "Unintended System Motion", "Image Orientation Incorrect", "Unintended System Motion" ], "reporter_state_code": "CA", "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": "20230106", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "55 YR", "patient_sex": "Female", "patient_weight": "69 KG", "patient_ethnicity": "Hispanic", "patient_race": "", "patient_problems": [ "Unspecified Tissue Injury", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20221207", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "16118479", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20221207", "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": "306877927", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY PROCEDURE, THE ENDOSCOPE IMAGE BECAME INVERTED AND RESULTED IN UNEXPECTED MOTION OF AN INSTRUMENT. THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES ASSOCIATE (CSA), WHO WAS PRESENT DURING THE CASE, REPORTED THAT THE INSTRUMENTS WERE MOVING IN THE OPPOSITE DIRECTION THAN THE SURGEON INTENDED. WHEN THE SURGEON TRIED TO PULL AN INSTRUMENT AWAY, THE INSTRUMENT ALLEGEDLY MOVED FORWARD AND DAMAGED THE LIVER. THE CSA SAID THE CUSTOMER WAS ABLE TO RESOLVE THE ISSUE BE REMOVING AND RESEATING THE ENDOSCOPE TWO TIMES. THE PROCEDURE WAS REPORTEDLY COMPLETED AS PLANNED. ISI CONTACTED THE SURGEON OF THIS PROCEDURE AND ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE COMPLAINT: THE INDICATION FOR THIS PROCEDURE WAS ACUTE CHOLECYSTITIS/CHOLEDOCHOLITHIASIS. THE SURGEON SAID THIS EVENT OCCURRED IMMEDIATELY AFTER THEY TOOK CONTROL AT THE SURGEON SIDE CONSOLE (SSC) WHILE THEY WERE TRYING TO SET-UP THE RETRACTION. THE PROGRASP FORCEPS INSTRUMENT REPORTEDLY WAS THE INSTRUMENT THAT MOVED DURING THIS EVENT. THE SURGEON REPORTED THAT THE PATIENT LOST 50CC OF BLOOD DUE TO THIS EVENT AND NO BLOOD TRANSFUSION WAS ADMINISTERED. THIS EVENT DELAYED THE PROCEDURE BY LESS 15 MINUTES AND DID NOT OCCUR DURING A CRITICAL TASK IN THE PROCEDURE. THE SURGEON REPORTED THAT THEY RESEATED THE ENDOSCOPE SEVERAL TIMES TO TROUBLESHOOT THIS ISSUE. THE SURGEON DID NOT REPORT ANY MEDICAL INTERVENTION DUE TO THIS COMPLICATION. THE SURGEON REPORTED THAT THIS EVENT HAD ¿NO ILL EFFECT¿ ON THE PROCEDURE OR PATIENT OUTCOME. THE SURGEON SAID THERE IS NO CONCERN OF LONG-TERM COMPLICATIONS WITH THE PATIENT, AND THE PATIENT DID NOT EXPERIENCED ANY POST-OPERATIVE COMPLICATIONS. THE PATIENT REPORTEDLY ¿RECOVERED UNEVENTFULLY¿ AND THEIR CARE PLAN DID NOT CHANGE. THE SURGEON SAID NO EVENTS OCCURRED THAT INCREASED THE SEVERITY OF THIS EVENT, AND THERE ARE NO IMAGES OR VIDEOS OF THIS EVENT." }, { "mdr_text_key": "306877928", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION HAS BEEN DEEMED TO BE PRODUCT RELATED. ISI HAS REQUESTED THE ENDOSCOPE USED DURING THIS EVENT BE RETURNED FOR EVALUATION, BUT THE PRODUCT HAS NOT BEEN RECEIVED. ALTHOUGH THE SURGEON REPORTED THAT THE PROGRASP FORCEPS INSTRUMENT MOVED IN AN UNEXPECTED DIRECTION, IT HAS BEEN DETERMINED THAT THIS WAS CAUSED BY THE ENDOSCOPE ROTATION ISSUE. ADDITIONALLY, AN INSTRUMENT LOG REVIEW SHOWS THE CUSTOMER HAS CONTINUED USE WITH THIS PARTICULAR PROGRASP FORCEPS INSTRUMENT IN SUBSEQUENT PROCEDURES. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A SYSTEM LOG REVIEW WAS PERFORMED BY A TSE FOR THIS PROCEDURE: NO RELEVANT ERRORS WERE OBSERVED DURING THIS PROCEDURE. A REVIEW OF THE INSTRUMENT LOGS FOR THIS PROCEDURE HAS BEEN PERFORMED AND THE FOLLOWING WAS OBSERVED: ALL MULTI-USE INSTRUMENTS USED IN THE CASE HAVE BEEN USED IN SUBSEQUENT PROCEDURES WITH THE EXCEPTION OF THE SINGLE-USE INSTRUMENTS AND THE FOLLOWING INSTRUMENTS: 30 ENDOSCOPE PLUS (PART #470057-08 / SERIAL #(B)(4), MEDIUM-LARGE CLIP APPLIER (PART #470327-12 / LOT #N11210628-0105). A SITE COMPLAINT HISTORY REVIEW WAS PERFORMED AND NO ADDITIONAL COMPLAINTS HAVE BEEN CREATED FOR ANY OF THE INSTRUMENTS USED DURING THIS PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY PROCEDURE, THE ENDOSCOPE IMAGE BECAME INVERTED, RESULTING WITH UNEXPECTED MOTION OF AN INSTRUMENT AND AN UNSPECIFIED LIVER INJURY." } ], "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": "" } ] }