{ "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": "2955842-2023-10130", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20230117", "manufacturer_address_2": "", "pma_pmn_number": "K191736", "date_of_event": "20221219", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20230117", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "770589", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230117", "brand_name": "DA VINCI", "generic_name": "ENDOSCOPE", "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": "470056-05", "catalog_number": "470056", "lot_number": "001005-0488", "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": "", "udi_public": "", "openfda": { "device_name": "Laparoscope, General & Plastic Surgery", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Unintended System Motion", "Unintended System Motion" ], "reporter_state_code": "GA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250731", "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": "20230117", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Unspecified Tissue Injury", "Hemorrhage/Blood Loss/Bleeding", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20221219", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "16188693", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20221219", "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": "307559558", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE OPERATIVE COMPLICATION CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A SYSTEM LOG REVIEW WAS PERFORMED FOR THIS PROCEDURE: NO RELEVANT ERRORS WERE OBSERVED DURING THIS PROCEDURE OR A SUMMARY OF RELEVANT ERRORS THAT WERE OBSERVED. NO IMAGE OR VIDEO CLIPS FOR THE REPORTED EVENT WERE SUBMITTED BY THE CUSTOMER FOR REVIEW. THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ENDOMETRIOSIS RESECTION PROCEDURE, THERE WAS A DELAY IN INSTRUMENT MOVEMENT AND THE ENDOSCOPE WAS NOT FLIPPING NORMAL ANGLE UP AND DOWN. THE DELAY WAS ISOLATED ONLY TO ONE ARM. AS A RESULT OF THE ISSUE, THE PATIENT REPORTEDLY SUSTAINED A LARGE BOWEL INJURY THAT WAS REPAIRED WITH SUTURES AND STITCHES. THE CUSTOMER REPORTED FAILURE MODE WAS RESOLVED AFTER THE SURGICAL STAFF REPLACED THE ENDOSCOPE AND THE CASE WAS COMPLETED ROBOTICALLY." }, { "mdr_text_key": "307559559", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ENDOMETRIOSIS RESECTION PROCEDURE, THERE WAS A DELAY IN INSTRUMENT MOVEMENT AND THE ENDOSCOPE WAS NOT FLIPPING NORMAL ANGLE UP AND DOWN. THE ENDOSCOPE WAS OBSERVED TO BE ROTATING ON ITS OWN. THIS OCCURRED AT THE START OF THE PROCEDURE AND ONLY OCCURRED ONCE. TECHNICAL SUPPORT (TS) WAS CONTACTED AND RECOMMENDED TO TRY A DIFFERENT ENDOSCOPE. THE ISSUE WAS RESOLVED WITH A PHONE FIX. DUE TO THE ISSUE, THE PATIENT SUSTAINED AN UNSPECIFIED LARGE BOWEL INJURY. THE TYPE AND SEVERITY OF THE BOWEL INJURY ARE UNKNOWN. IT IS ALSO UNCLEAR HOW THE COMPLICATION OCCURRED AND WHAT TASK WAS BEING PERFORMED AT TIME OF THE INJURY. A GENERAL SURGEON WAS CALLED IN AND REPAIRED THE LARGE BOWEL INJURY WITH SUTURES AND STITCHES. THE ESTIMATED BLOOD LOSS WAS CONSIDERED NEGLIGIBLE AND WAS LESS THAN 15 MILLILITERS. THERE WAS A DELAY OF 15-20 MINUTES. THE SURGEON INDICATED THAT AFTER THE ENDOSCOPE WAS CHANGED, THE SURGICAL STAFF WAS ABLE TO COMPLETE THE CASE ROBOTICALLY WITH NO FURTHER ISSUES. THE PATIENT HAD NO POST-OPERATIVE COMPLICATIONS AND IS DISCHARGED FROM THE HOSPITAL." } ], "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": "" } ] }