{ "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": "2955842-2013-04610", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20131024", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130924", "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": [ "Other", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20131025", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "547053", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131024", "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": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20130930", "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": [ "Detachment Of Device Component", "Component Falling", "Entrapment of Device" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250813", "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": "20131024", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "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": "20130924", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3428434", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130924", "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": "3896364", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6) 2013, THE INTUITIVE SURGICAL INC. (ISI) CLINICAL SALES REP (CSR) REPORTED A NEEDLE DROPPING INTO A PATIENT DURING A DA VINCI SI PROSTATECTOMY PROCEDURE ON (B)(6) 2013. THE CSR REPORTED A LARGE NEEDLE DRIVER INSTRUMENT THAT WAS INSTALLED ON THE PATIENT SIDE MANIPULATOR 2 (PSM2) INADVERTENTLY OPENED AND THE NEEDLE HAD DROPPED INTO THE PATIENT. THE SITE RESEATED THE INSTRUMENT AND WAS ABLE TO OPERATE NORMAL. A C-ARM WAS USED; HOWEVER, THE SITE WAS UNABLE TO LOCATE THE NEEDLE. INFORMATION DETAILING THE EVENTS LEADING TO THE ALLEGED INADVERTENT DROP WAS NOT REPORTED AT THE TIME. ON (B)(6) 2013, ISI SPOKE WITH THE ISI CSR, WHO WAS THE INITIAL REPORTER. HE CONFIRMED WITH THE SURGEON THAT THE DROPPED NEEDLE HAS NOT BEEN RETRIEVED; HOWEVER, HE IS NOT AWARE OF THE PATIENT SUSTAINING ANY POST-OPERATIVE COMPLICATIONS. HE WAS UNABLE TO INDICATE HOW LONG THE INSTRUMENT WAS IN USE BEFORE THE NEEDLE DROPPED OUT OF THE INSTRUMENT. HE ALSO INDICATED THAT THE SURGEON COMPLETED THE PROCEDURE WITH THE SAME INSTRUMENT WITH NO ISSUES AFTER IT WAS RESEATED IN THE PSM2. THE SCRUB TECH ALSO INSPECTED THE INSTRUMENT AFTER THE PROCEDURE AND IT APPEARED FINE. HE WAS UNABLE TO PROVIDE THE LOT NUMBER OF THE LARGE NEEDLE DRIVER INSTRUMENT INVOLVED WITH THE REPORTED EVENT. ISI ATTEMPTED TO CONTACT THE SURGEON; HOWEVER, AS OF THE DATE OF THE REPORT NO ADDITIONAL INFORMATION HAS BEEN OBTAINED." }, { "mdr_text_key": "11100723", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(4) 2013, AN ISI FIELD SERVICE ENGINEER (FSE) WENT ON SITE AND INSPECTED THE PSM2 AND CHECKED THE CABLE TENSIONS. THE FSE NOTED THAT THE CABLE TENSION FOR ONE OF THE CABLES ON THE AXIS 6 WAS OUT OF SPECIFICATIONS. THE CABLE TENSION WAS ADJUSTED TO BE WITHIN SPECIFICATIONS. THE FSE HEARD A CLICKING SOUND FROM THE PSM2 DURING ONE OF THE PERFORMANCE TEST, WHICH WAS DETERMINED TO OCCUR WHEN AXIS 2 WAS MANIPULATED. THE PSM2 WAS REPLACED AND SYSTEM WAS VERIFIED AS READY FOR USE. ON (B)(4) 2013, THE PSM2 RETURNED AND EVALUATED BY FAILURE ANALYSIS. A LARGE NEEDLE DRIVER INSTRUMENT WAS INSTALLED ON THE RETURNED PSM2. THE INSTRUMENT WAS GRASPING A SMALL OBJECT AND DID NOT FALL OFF THE INSTRUMENT. FAILURE ANALYSIS WAS UNABLE TO REPLICATE THE CLICKING ISSUE. AXIS 4 AND AXIS 6 WERE OUT OF SPECIFICATIONS; HOWEVER, ALL OTHER AXES WERE WITHIN SPECIFICATIONS. AXIS 6 IS ONE OF THE AXES THAT CONTROL THE OPENING AND CLOSING OF THE INSTRUMENT'S JAWS. AS OF THE DATE OF THIS REPORT, THERE HAS BEEN NO REPORTED COMPLAINTS WITH THE PSM2 WITH THIS DA VINCI S SYSTEM. A FOLLOWUP MDR WILL BE SUBMITTED ONCE NEW INFORMATION IS OBTAINED. BASED ON THE PROVIDED INFORMATION, THIS COMPLAINT IS BEING REPORTED BECAUSE A NEEDLE INADVERTENTLY WAS DROPPED INSIDE THE PATIENT DURING A DA VINCI SI PROSTATECTOMY PROCEDURE. IN ADDITION, CABLE TENSIONS ON THE PSM2 WERE FOUND TO BE OUT OF SPECIFICATIONS. THE PSM2 HAS BEEN REPLACED. THIS REPORT DOES NOT ADMIT THAT THE REPORT OR INFORMATION SUBMITTED UNDER THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, INTUITIVE SURGICAL OR INTUITIVE SURGICAL EMPLOYEES, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT." } ], "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": "" } ] }