{ "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": "2955842-2013-05873", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20131220", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20131016", "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": [ "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20131223", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "668801", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131220", "brand_name": "UNKNOWN DA VINCI ENDOWRIST INSTRUMENT", "generic_name": "", "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": "UNKNOWN", "catalog_number": "", "lot_number": "UNKNOWN", "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": [ "Material Frayed" ], "reporter_state_code": "MI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250815", "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": "20131220", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20131122", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3531685", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131122", "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": "4121073", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI MYOMECTOMY PROCEDURE, THE SURGEON MADE THE DECISION TO CONVERT THE PLANNED SURGICAL PROCEDURE TO A LAPARATOMY TO COMPLETE THE DISSECTION OF A MASSIVE FIBROID FOR REMOVAL. A RADIOGRAPH WAS PERFORMED POST THE SURGICAL PROCEDURE DUE TO THE PATIENT'S BLOOD LOSS APPROXIMATELY 1000ML) AT WHICH TIME IT WAS DISCOVERED THAT THE PATIENT HAD RETAINED A 1CM LINEAR AND FRAYED METALLIC FOREIGN BODY. THE FOREIGN BODY WAS IN THE PATIENT'S RIGHT UPPER ABDOMEN QUADRANT, IN FRONT OF THE ASCENDING COLON AND DEEP INTO THE ABDOMEN WALL. A DIAGNOSTIC LAPAROSCOPY WITH FLUOROSCOPIC GUIDANCE CONFIRMED THAT THE FOREIGN OBJECT WAS WITHIN THE PATIENT'S OMENTUM. THE SURGEON STATED THAT THE FOREIGN OBJECT WAS A PIECE OF PULLEY TYPE WIRE ON THE WRISTED ARM OF THE INSTRUMENT. NO OTHER INFORMATION WAS PROVIDED." }, { "mdr_text_key": "11384411", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION, THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. INTUITIVE SURGICAL, INC. HAS BEEN MADE SEVERAL ATTEMPTS TO GATHER ADDITIONAL INFORMATION FROM THE INITIAL REPORTER OF THIS COMPLAINT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST ENGINEERING EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS DISCOVERED POST -OP MYOMECTOMY PROCEDURE USING THE DA VINCI SURGICAL SYSTEM AND OPEN SURGICAL TECHNIQUES THAT THE PATIENT RETAINED AN INSTRUMENT FRAGMENT FROM AN ENDOWRIST INSTRUMENT." } ], "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": "" } ] }