BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK CUTTING FORCEP

    MDR report key: 1062431 · Received May 31, 2008

    Report

    Report Number
    1062431
    Event Type
    Malfunction
    Date Received
    May 31, 2008
    Date of Event
    March 14, 2008
    Report Date
    May 31, 2008
    Manufacturer
    GYRUS MEDICAL, INC.
    Product Code
    GEN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS USING THE DEVICE TO GRAB THE CERVICAL TISSUE AND THE PIECE OF THE DEVICE TIP BROKE OFF. THE DEVICE WAS REPLACED. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PK CUTTING FORCEP FORCEPS, CUTTING, ELECTROSURGICAL GEN GYRUS MEDICAL, INC. * 8044103

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR