BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO OSCILLATING SAW

    MDR report key: 1960047 · Received December 6, 2010

    Report

    Report Number
    1811755-2010-01906
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 16, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE HAS NOT YET BEEN REC'D AT THE MFR FOR TESTING. AN EVAL WILL BE CONDUCTED UPON RECEIPT OF THE DEVICE, AND A FOLLOW-UP REPORT WILL BE SUBMITTED IF THE RESULTS OF THE QUALITY INVESTIGATION REQUIRE ONE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE BEGAN OVERHEATING DURING A ROUTINE MAINTENANCE VISIT AND IN A NON-STERILE ENVIRONMENT. 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 MICRO OSCILLATING SAW SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHMENT ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK