BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRODEBRIDER 1898200T IGS M4

    MDR report key: 3122647 · Received May 21, 2013

    Report

    Report Number
    1045254-2013-00392
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    April 26, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ERL
    PMA / PMN Number
    K041413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION AND REPAIR. THE PRODUCT ANALYSIS FOUND THE HANDPIECE WAS NOT WORKING UPON INSPECTION. THE BEARINGS WERE CORRODED AND WOULD NOT ALLOW THE SHAFT TO ROTATE; THEREFORE, THE REPORTED OVERHEATING COULD NOT BE CONFIRMED. THE HAND PIECE WAS REPAIRED, TESTED TO PRODUCT SPECIFICATIONS, AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED FOR EVALUATION AND REPAIR WITH A REPORT THAT THE HANDPIECE WAS HEATING UP. THERE WAS NO PATIENT OR USER IMPACT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224428 MICRODEBRIDER 1898200T IGS M4 DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL MEDTRONIC XOMED, INC. 1898200T 205502398

    Patients

    Seq Age Sex Outcome Treatment
    1