BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL TRIGGER ROTARY

    MDR report key: 2102540 · Received May 19, 2011

    Report

    Report Number
    1811755-2011-01818
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 29, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS REC'D AT THE MANUFACTURER FOR SERVICE AND EVALUATION. DURING THE INVESTIGATION AN OVERHEATING CONDITION WAS FOUND AND THEN REPORTED. BASED ON THE INVESTIGATION DETAILS, SERVICE REPLACED AN ELECTRICAL COMPONENT AND DID A CLEAN, LUBE, AND ADJUST TO THE DEVICE. THE HANDPIECE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE HANDPIECE WAS RETURNED TO THE MANUFACTURER FOR SERVICE, AND DURING THE INVESTIGATION THE DEVICE BEGAN TO OVERHEAT. THERE WAS NO PT INVOLVEMENT DURING THIS EVENT. THIS DID NOT OCCUR DURING A SURGICAL PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUAL TRIGGER ROTARY KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK