{ "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": "I", "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": "2955842-2019-10233", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20190401", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20181029", "reprocessed_and_reused_flag": "I", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "NURSE", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "HEALTH PROFESSIONAL", "OTHER" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20190401", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "263195", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190401", "brand_name": "DA VINCI", "generic_name": "DA VINCI SURGICAL SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "950 KIFER RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "94086", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "94086", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "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": [ "Insufficient Device Problem Information", "Insufficient Device Problem Information" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250812", "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": "20190401", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20190305", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8471529", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20190305", "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": "140587403", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4) - BASED ON THE CURRENT INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE OF THE REPORTED FALLING OF A NEEDLE INTO THE PATIENT. ISI DOES NOT MANUFACTURE NEEDLES. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. THE VOLUNTARY REPORT DOES NOT CONTAIN ANY CONTACT INFORMATION. THEREFORE, NO FOLLOW-UP INVESTIGATION COULD BE CONDUCTED. THE FOLLOWING INFORMATION IS UNKNOWN: WHAT SPECIFIC HOSPITAL PROVIDED THE DA VINCI-ASSISTED SURGICAL PROCEDURE, THE NAME OF THE SURGEON WHO PERFORMED THE DA VINCI-ASSISTED SURGICAL PROCEDURE, AND WHAT SPECIFIC DA VINCI SURGICAL SYSTEM (MODEL/SERIAL #) WAS USED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED HYSTERECTOMY SURGICAL PROCEDURE, A NEEDLE MAY HAVE FALLEN INSIDE THE PATIENT AND WAS NOT DISCOVERED UNTIL PORT CLOSURE. AT THIS TIME, IT IS UNKNOWN IF THE NEEDLE WAS RETRIEVED. ADDITIONALLY, AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE NEEDLE TO FALL INSIDE THE PATIENT." }, { "mdr_text_key": "140587404", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6) 2019, INTUITIVE SURGICAL, INC. (ISI) RECEIVED SUS VOLUNTARY EVENT REPORT #MW5084047 WITH THE FOLLOWING EVENT DESCRIPTION: ¿NEEDLE FROM DAVINCI ROBOT FELL INTO PT¿S SURGICAL WOUND DURING ROBOTIC HYSTERECTOMY. NEEDLE MAY HAVE FALLEN INTO SURGICAL WOUND AT SOME POINT DURING CASE. DID NOT DISCOVER UNTIL AFTER CLOSURE. NEEDLE TOO SMALL TO DETECT ON X-RAY. PT DOING WELL. SURGEON NOTIFIED. HOOK ON THE MONOPOLAR STOPPED WORKING.¿" } ], "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": "" } ] }