BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL HANDPIECE

    MDR report key: 2964249 · Received February 15, 2013

    Report

    Report Number
    0001811755-2013-00291
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 24, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    LFL
    PMA / PMN Number
    K010309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE DEVICE EVALUATION, THE REPORTED OVERHEATING COULD NOT BE DUPLICATED. NO COMPONENTS OF THE DEVICE WERE FOUND TO BE OUT OF SPECIFICATION. UPON FOLLOW-UP WITH THE USER FACILITY, IT WAS REPORTED THAT THE TIP USED WITH THE DEVICE HAD BEEN DISCARDED. THE DEVICE WAS SERVICED FOR PREVENTATIVE MAINTENANCE, AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SETUP PRIOR TO A SURGICAL PROCEDURE AT THE USER FACILITY, THE HANDPIECE WAS OVERHEATING. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67656 UNIVERSAL HANDPIECE INSTRUMENT, UILTRASONIC SURGICAL LFL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1