BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTRUMENT ARM DRAPE

    MDR report key: 16511936 · Received March 9, 2023

    Report

    Report Number
    16511936
    Event Type
    Malfunction
    Date Received
    March 9, 2023
    Date of Event
    March 2, 2023
    Report Date
    March 2, 2023
    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

    TECH NOTICED MISSING MAGNETS WHEN DRAPING ROBOT. DRAPES WERE REMOVED AND NEW DRAPE OPENED FOR DRAPING. ON THREE SEPARATE OCCASIONS, WE HAVE HAD ROBOTIC INSTRUMENT ARM DRAPES THAT ARE MISSING MAGNETS. ALL LOT NUMBERS VARY. A PRIOR EVENT REPORT WAS FILLED OUT FOR THE SAME ISSUE. NO MAGNETS: LOT# DM4224323. NO MAGNETS: LOT# DM5224120. ONE MAGNET: LOT# DM8224123 OR DM7224226.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1550103 INSTRUMENT ARM DRAPE SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT NAY INTUITIVE SURGICAL, INC. DM4224323

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown