{ "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": "2955842-2014-03587", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20140611", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20140512", "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": "20140612", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "344659", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140611", "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 A6.0P8", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "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": [ "Component Missing" ], "reporter_state_code": "VA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250725", "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": "20140611", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Device Embedded In Tissue or Plaque" ] } ], "distributor_city": "", "date_report": "20140512", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3867483", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140512", "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": "17620533", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE AS TO WHY THE NEEDLE WAS LOST DURING THE DA VINCI SURGICAL PROCEDURE. THERE IS NO REPORT THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2014. NO SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: MULTIPLE X-RAYS WERE PERFORMED TO HELP SEARCH FOR A NEEDLE THAT WAS LOST DURING ATTEMPTED REMOVAL OF THE NEEDLE THROUGH A NON-ROBOTIC ASSIST PORT. IN ADDITION, THE SURGEON HAD TO WIDEN THE INCISION PORT IN ORDER TO RETRIEVE THE NEEDLE. THERE IS NO INDICATION, HOWEVER, THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM CAUSED OR CONTRIBUTED TO THE NEEDLE BEING LOST DURING THE PROCEDURE." }, { "mdr_text_key": "17296142", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI HYSTERECTOMY PROCEDURE, THE ASSISTING SURGEON ATTEMPTED TO REMOVE A NEEDLE THROUGH A LAPAROSCOPIC ASSIST PORT AND THE NEEDLE WAS LOST. AFTER THE VAGINAL CUFF WAS CLOSED, THE ROBOT WAS UNDOCKED FROM THE PATIENT. THE NEEDLE WAS FOUND IN THE ABDOMINAL WALL AFTER AN X-RAY WAS PERFORMED. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE INITIAL REPORTER WAS PRESENT DURING THE DA VINCI SURGICAL PROCEDURE. TOWARDS THE END OF THE SURGICAL PROCEDURE WHILE THE SURGEON WAS CLOSING THE VAGINAL CUFF, THE ASSISTING SURGEON ATTEMPTED TO REMOVE A NEEDLE THROUGH A LAPAROSCOPIC ASSIST PORT USING AN UNIDENTIFIED NON-ISI LAPAROSCOPIC INSTRUMENT AND WITHOUT DIRECT VISUALIZATION. THE INITIAL REPORTER STATED THAT THE LAPAROSCOPIC ASSIST PORT WAS ACTUALLY A DA VINCI PORT BUT WAS SOLELY USED AS A LAPAROSCOPIC ASSIST PORT BY THE SURGICAL STAFF. THE INITIAL REPORTER INDICATED THAT THE DA VINCI SURGICAL SYSTEM WAS NEVER DOCKED TO THE LAPAROSCOPIC ASSIST PORT INVOLVED WITH THIS COMPLAINT. AFTER THE ASSISTING SURGEON REMOVED THE LAPAROSCOPIC INSTRUMENT FROM THE CANNULA, HE REALIZED THAT THE NEEDLE WAS MISSING. AFTER THE PATIENT'S VAGINAL CUFF WAS CLOSED, MULTIPLE X-RAYS WERE PERFORMED TO SEARCH FOR THE MISSING NEEDLE. ACCORDING TO THE INITIAL REPORTER, THE NEEDLE WAS FOUND EMBEDDED IN TISSUE BY THE LAPAROSCOPIC ASSIST PORT. THE SURGEON HAD TO WIDEN THE INCISION OF THE LAPAROSCOPIC ASSIST PORT IN ORDER TO RETRIEVE THE NEEDLE. NO POST-OPERATIVE COMPLICATIONS WERE REPORTED. THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE 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": "" } ] }