BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLORADO NEEDLE, 3 CM STRAIGHT (3/32") SLEEVE

    MDR report key: 3831645 · Received May 26, 2014

    Report

    Report Number
    0008010177-2014-00137
    Event Type
    Malfunction
    Date Received
    May 26, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-CORK
    Product Code
    GEI
    PMA / PMN Number
    K033232
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.

    Additional Manufacturer Narrative · 1

    THE VISUAL INSPECTION CONFIRMED THE REPORTED EVENT, THERE ARE BURNED DAMAGES IN THE ISOLATION OF THE NEEDLES. THE DAMAGES ARE SURROUNDED BY PRINTS/DAMAGES OF MEDICAL INSTRUMENTS, WHICH PREDAMAGED THE ISOLATION. THE IFU STATES CLEARLY THAT NO OTHER DEVICES THAN THOSE SPECIFIED IN THE INSTRUCTIONS ARE TO BE USED. BENDING, STRAIGHTENING OR REMOVING THE NEEDLE BY MEANS OF FORCEPS OR PLIERS IS NOT PERMITTED. DUE TO THE PREDAMAGES THE ISOLATION GETS THINNER. THEREFORE THE APPLIED VOLTAGE HEATS UP THE THINNER ISOLATION AND THE BURNED DAMAGES APPEAR. SUMMARIZING THE INVESTIGATION THE FAILURE MODE (DAMAGED/BURNED ISOLATION) CAN BE ATTRIBUTED TO A USER RELATED ROOT CAUSE (PREDAMAGES RESULTING FROM MEDICAL INSTRUMENTS).

    Description of Event or Problem · 1

    PLASTIC INSULATION ON COLORADO MICRODISSECTION NEEDLE SHOWED SIGNS OF BURNING WHEN IN USE.

    Description of Event or Problem · 1

    PLASTIC INSULATION ON COLORADO MICRODISSECTION NEEDLE SHOWED SIGNS OF BURNING WHEN IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309956 COLORADO NEEDLE, 3 CM STRAIGHT (3/32") SLEEVE INSTRUMENT GEI STRYKER ORTHOPAEDICS-CORK 318110113317077H8

    Patients

    Seq Age Sex Outcome Treatment
    1