BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL TRIGGER ROTARY

    MDR report key: 2082113 · Received April 26, 2011

    Report

    Report Number
    1811755-2011-01435
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 7, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RECEIVED AT THE MANUFACTURER FOR EVALUATION, AND THE REPORTED CONDITION OF THE DEVICE LEAKING WAS DUPLICATED. THE DEVICE WAS LEAKING WHAT APPEARED TO BE DETERGENT. BASED ON THE INVESTIGATION DETAILS, SERVICE PERFORMED MAINTENANCE ON THE DEVICE AND DID A CLEAN, LUBE, AND ADJUST. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER. A MANUFACTURER REPRESENTATIVE REVIEWED CLEANING PROCESSES WITH THE ACCOUNT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE BEGAN LEAKING AN OIL SUBSTANCE PRIOR TO THE START OF A SURGICAL PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE THE PLANNED 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