BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SABO SAG SAW

    MDR report key: 2070826 · Received April 15, 2011

    Report

    Report Number
    1811755-2011-01285
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS REC'D AT THE MANUFACTURER FOR EVALUATION, BUT BASED ON THE INVESTIGATION DETAILS, THE REPORTED CONDITION OF THE DEVICE LEAKING AN OIL SUBSTANCE COULD NOT BE DUPLICATED. MAINTENANCE WAS PERFORMED, AND SERVICE DID A CLEAN, LUBE, AND ADJUSTMENT TO THE DEVICE. THE HANDPIECE WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE BEGAN LEAKING AN OIL SUBSTANCE WHILE THE EQUIPMENT WAS BEING TESTED. THIS DID NOT OCCUR DURING A SURGICAL PROCEDURE. THERE WAS NO PT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SABO SAG SAW KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK