BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOLUBE-III-IRR

    MDR report key: 4181831 · Received October 17, 2014

    Report

    Report Number
    1045834-2014-14011
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    September 20, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    GEY
    PMA / PMN Number
    PK970530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING PRE-REPAIR ASSESSMENT PERFORMED BY A TECHNICIAN, FUNCTIONAL TESTING WAS PERFORMED AND REVEALED THE O-RINGS WAS DAMAGED. THIS WAS ATTRIBUTED TO NORMAL WEAR. VARIOUS PARTS WERE REPLACED. DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    DEVICE WAS RETURNED FOR REPAIR. DURING INSPECTION, TECHNICIAN FOUND THAT THE FILTER WAS MISSING AND A LEAK AT THE LEVEL INDICATOR. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662264 AUTOLUBE-III-IRR MOTOR, SURGICAL INSTRUMENT, AC-POWERED GEY DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1