{ "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": "HOSPITAL", "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": "2955842-2013-02663", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20130719", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130619", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20130722", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "337619", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130719", "brand_name": "DA VINCI SI SURGICAL SYSTEM", "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL,INC.", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "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": "IS3000 A6.0P5", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "Yes", "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": [ "Difficult to Open or Close" ], "reporter_state_code": "NJ", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250808", "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": "20130719", "sequence_number_treatment": [ "DA VINCI SI INSTRUMENTS, ACCESSORIES AND ESU." ], "sequence_number_outcome": [ "Other" ], "patient_age": "23 YR", "patient_sex": "", "patient_weight": "66", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Code Available" ] } ], "distributor_city": "", "date_report": "20130619", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3238488", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130619", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "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": "3689203", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI SI CHOLECYSTECTOMY PROCEDURE, THE CANNULA MOUNT ON THE PATIENT SIDE MANIPULATOR (PSM) ARM WOULD NOT STAY CLOSED. IT WAS ALSO REPORTED THAT THE PATIENT'S GALLBLADDER, WHICH WAS TO BE REMOVED AS PART OF THE SURGICAL PROCEDURE WAS NICKED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED; HOWEVER; DUE TO THE CANNULA MOUNT NOT STAYING CLOSED, THE SURGICAL TIME WAS LENGTHENED APPROXIMATELY 2 HOURS." }, { "mdr_text_key": "10946751", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER (FSE) CONFIRMED THE CUSTOMER REPORTED FAILURE MODE. THE FSE OBSERVED THAT THE CANNULA MOUNT ON THE PATIENT SIDE MANIPULATOR ARM WAS LOOSE, THUS THE CLAMPS ON THE CANNULA MOUNT WOULD NOT STAY CLOSED. THE FSE FOUND THAT THE CANNULA MOUNT DID NOT EXHIBIT ANY PHYSICAL DAMAGE AND CONCLUDED THAT THE CANNULA MOUNT BECAME LOOSE DUE TO WEAR AND TEAR. THE CANNULA MOUNT ACCESSORY IS ATTACHED TO THE PSM AND IS DESIGNED TO HOLD THE CANNULA SECURELY IN PLACE, OUTSIDE OF THE PATIENT'S CAVITY. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED PSM CANNULA MOUNT ACCESSORY. IT IS UNKNOWN IF THE CANNULA MOUNT ISSUE IS RELATED TO THE REPORTED NICKING OF THE PATIENT'S GALLBLADDER. INTUITIVE SURGICAL, INC. HAS CONTACTED THE SITE SEVERAL TIMES TO VERIFY ADDITIONAL INFORMATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S GALL BLADDER WAS NICKED DURING A DA VINCI SURGICAL PROCEDURE." } ], "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": "" } ] }