BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL 3334800FCE VISAO 80K HANDPIECE-FCE

    MDR report key: 2973104 · Received February 21, 2013

    Report

    Report Number
    1045254-2013-00138
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Report Date
    January 25, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ERL
    PMA / PMN Number
    K011321
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND REPAIR. THE ALLEGED "OVERHEATING" COULD NOT BE DUPLICATED OR CONFIRMED DUE TO THE DEVICE BEING NON-FUNCTIONAL UPON ARRIVAL...IN LIEU OF THIS, ANALYSIS DID FIND THE MOTOR BEARINGS WERE CORRODED DUE TO SALINE. THE DEVICE WAS REPAIRED AND TESTED TO SPECIFICATIONS AND HAS BEEN RETURNED TO THE CUSTOMER. A REVIEW OF THE DEVICE MAINTENANCE HISTORY FOUND THE DEVICE WAS RETURNED TO SERVICE AND REPAIR IN 2009 FOR UNSPECIFIED REASONS, WHERE THE SERVICE TECHNICIAN INDICATED "HANDPIECE RUNNING ROUGH"; NO FURTHER MAINTENANCE HISTORY WAS NOTED FOR THIS DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE WAS OVERHEATING WHILE IN USE. THERE WAS NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76498 DRILL 3334800FCE VISAO 80K HANDPIECE-FCE DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL MEDTRONIC XOMED, INC. 3334800FCE 42813700

    Patients

    Seq Age Sex Outcome Treatment
    1