BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARM DRAPE

    MDR report key: 20320932 · Received September 27, 2024

    Report

    Report Number
    20320932
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Date of Event
    September 5, 2024
    Report Date
    September 5, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    AFTER OPENING A DA VINCI XI INSTRUMENT ARM DRAPE, IT WAS DISCOVERED THAT THE DRAPE HAD MALFORMED STAYS ALONG THE PORTION OF THE DRAPE FROM THE HEAD TO THE PORT. ST (SURGICAL TECHNICIAN) DRAPING THE ROBOT COULD NOT STRAIGHTEN THE DRAPE STAYS WITHOUT POSSIBLY TEARING THE DRAPE. A NEW INSTRUMENT ARM DRAPE WAS RETRIEVED AND USED. THE ST REPORTED THAT SHE HAD SEEN THIS MALFORMATION MORE OFTEN RECENTLY FOR OTHER ROBOT PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1684951 ARM DRAPE SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT NAY INTUITIVE SURGICAL, INC. 470015 086064

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female