BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER FLYTE HOOD, PEEL-AWAY

    MDR report key: 22534612 · Received July 17, 2025

    Report

    Report Number
    MW5172880
    Event Type
    Malfunction
    Date Received
    July 17, 2025
    Report Date
    July 14, 2025
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    FYA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    METAL SHAVING FOUND INSIDE PACKING OF STRYKER FLYTE HOOD, PEEL-AWAY. METAL SHAVING WAS IDENTIFIED PRIOR TO OPENING ONTO THE FIELD. PRODUCT WAS REMOVED FROM OPERATING ROOM. REF: 0408-800-500, LOT:0000822522, EXP: 04/24/2028.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2752057 STRYKER FLYTE HOOD, PEEL-AWAY GOWN, SURGICAL FYA STRYKER INSTRUMENTS 0000822522

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other