BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 6 PRECISION HANDPIECE

    MDR report key: 2132314 · Received June 11, 2011

    Report

    Report Number
    1811755-2011-02126
    Event Type
    Malfunction
    Date Received
    June 11, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 23, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RECEIVED AT THE MFR FOR EVAL, BUT BASED ON THE INVESTIGATION DETAILS THE REPORTED CONDITION OF THE DEVICE OVERHEATING DURING USAGE COULD NOT BE DUPLICATED. SERVICE COMPLETED ANY NECESSARY MAINTENANCE OR REPAIRS, AND THE DEVICE WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE OVERHEATED. THIS DID NOT OCCUR DURING A SURGICAL PROCEDURE, SO THERE WAS NO PT INVOLVEMENT. THERE WAS NO USER INJURY OR ANY OTHER ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 6 PRECISION HANDPIECE KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK