BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYRUS ACMI - PK TECHNOLOGY (PKS CUTTING FORCEPS)

    MDR report key: 1278046 · Received December 15, 2008

    Report

    Report Number
    1278046
    Event Type
    Malfunction
    Date Received
    December 15, 2008
    Date of Event
    December 10, 2008
    Report Date
    December 15, 2008
    Manufacturer
    GYRUS ACMI
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN WAS USING THE GYRUS PKU CUTTING FORCEPS AND IT DID NOT WORK (WOULD NOT COAGULATE). STAFF INITIALLY CHANGED OUT THE CORD, BUT DID NOT RESOLVE PROBLEM. DEVICE WAS REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE.====================== MANUFACTURER RESPONSE FOR PKS CUTTING FORCEPS, GYRUS ACMI - PK TECHNOLOGY======================MANUFACTURER PROVIDED RGA# FOR PRODUCT EVALUATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYRUS ACMI - PK TECHNOLOGY (PKS CUTTING FORCEPS) HANDPIECE, ESU GEI GYRUS ACMI 3000PK 8227048

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR