BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROBOTIC SURGICAL DRAPE

    MDR report key: 7334057 · Received March 13, 2018

    Report

    Report Number
    7334057
    Event Type
    Malfunction
    Date Received
    March 13, 2018
    Date of Event
    January 15, 2018
    Report Date
    March 7, 2018
    Manufacturer
    HALYARD HEALTH, INC.
    Product Code
    KKX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS IS A DISPOSABLE CUSTOM ROBOTIC DRAPE MADE BY HALYARD THAT IS SUPPLIED IN A CUSTOM PACK FOR HOSPITAL BY (B)(4). WHEN DRAPING THE PATIENT, THERE HAVE BEEN MULTIPLE INSTANCES WHEN THIS DRAPE HAS SPLIT/TORN/SEPARATED AT EITHER THE CHEST SEAM AND/OR THE LEG SEAMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177441 ROBOTIC SURGICAL DRAPE DRAPE, SURGICAL KKX HALYARD HEALTH, INC. CDRO64D 749171

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR