BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENT PRECISION CUTTER AGGRESSIVE SERRATED ESSX/HUMMER 4

    MDR report key: 2062755 · Received April 15, 2011

    Report

    Report Number
    2062755
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 15, 2011
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    FZT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VT, US

    Narratives

    Description of Event or Problem · 1

    AS THE SURGEON TESTED THE CUTTER PRIOR TO ACTUAL USE ON PATIENT, CUTTER DID NOT WORK. SURGEON REQUESTED ANOTHER CUTTER WHICH DID WORK. IT RESULTED IN A MOMENTARY DELAY IN THE PROCEDURE RESULTED. THERE WAS NO ADVERSE PATIENT EVENT.======= REPORTER RESPONSEREPORTER INDICATED THEY DID NOT HAVE PROBLEMS WITH THE AGGRESSIVE SERRATED CUTTER BEFORE. THE CUTTER DID NOT SPIN WHEN CONNECTED. OPERATOR ERROR WAS NOT DISCARDED AS A POSSIBILITY. THE PROBLEM WAS NARROWED TO THE AGGRESSIVE SERRATED CUTTER ONLY. NO OBSERVABLE MANUFACTURING PROBLEM WAS NOTED ON THE DEVICE OR THE ACCESSORIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENT PRECISION CUTTER AGGRESSIVE SERRATED ESSX/HUMMER 4 ENT CUTTER FZT STRYKER ENDOSCOPY * 10221CG2

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR