BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SP

    MDR report key: 21939097 · Received April 30, 2025

    Report

    Report Number
    2955842-2025-17046
    Event Type
    Injury
    Date Received
    April 30, 2025
    Date of Event
    April 2, 2025
    Report Date
    April 2, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114605
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE WAS UNABLE TO REPRODUCE THE CUSTOMER REPORTED ISSUE. HOWEVER, THE FSE REPLACED PATIENT SIDE MANIPULATOR (PSM) #2 DUE TO THE CUSTOMER'S CLAIMED THAT THE INSTRUMENT STERILE ADAPTER POPPED OFF AND WOULD NOT STAY ENGAGED. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED PSM #2 INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE PSM WAS ANALYZED AND FOUND TO HAVE NO FAILURES. DURING VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE THE COMPONENT FUNCTIONED AS EXPECTED. MULTIPLE STERILE ADAPTERS WERE INSTALLED BUT NO ISSUES WERE FOUND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED RADICAL EXTRAPERITONEAL PROSTATECTOMY WITH LYMPHADENECTOMY PROCEDURE, THE INSTRUMENT DRIVE ON PATIENT SIDE MANIPULATOR (PSM) #2 WAS NOT HOLDING THE STERILE ADAPTER (SA). THE ISSUE WAS IDENTIFIED WHILE THE OPERATING ROOM (OR) STAFF WAS SETTING UP FOR THE PROCEDURE. THE CUSTOMER HAD ALREADY RE-DRAPED BUT THE ISSUE REMAINED WITH A NEW DRAPE. WHEN THE CUSTOMER ENGAGED THE SA, IT SEEMED LIKE IT WOULD INITIALLY ENGAGE, BUT WHEN THEY TOUCHED THE SA ON PSM #2, IT FELL OFF. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) RECOMMENDED CHECKING THE WHEELS/DISK AND POGO PINS ON PSM #2. THE CALLER STATED ALL OF THE WHEELS AND THE POGO PINS SEEMED LIKE THEY WERE FREE TO MOVE AND SPONGY. THE CUSTOMER PRESSED THE INSTRUMENT RELEASE BUTTON ON THE PSM #2 AND THEN TRIED TO RE-ENGAGE THE SA ON THE PSM #2 WITH NO CHANGE. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. AT THIS TIME, IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE WAS NOTED AFTER ANESTHESIA WAS ALREADY ADMINISTERED AND PORTS HAD BEEN PLACED. THERE WAS NO INJURY TO THE PATIENT. THE CUSTOMER WAS PERFORMING MEDIASTINAL MASS RESECTION. THE PROCEDURE WAS CONVERTED FROM AN SP DA VINCI-ASSISTED SURGICAL PROCEDURE TO AN XI DA VINCI-ASSISTED SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2356603 DA VINCI SP PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380601-34 N/A 00886874114605

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES