BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL 3334800 VISAO 80K HANDPIECE

    MDR report key: 3043120 · Received April 9, 2013

    Report

    Report Number
    1045254-2013-00322
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 10, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ERL
    PMA / PMN Number
    K011321
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE HAND PIECE FAILED THE INITIAL PRE-TEMPERATURE TEST. THE TEMPERATURE READINGS WERE NOSE-155, MIDDLE-165, AND REAR-200. ALL EXCEEDED THE TEMPERATURE OF 120 DEGREES. THE DEVICE WAS DISASSEMBLED AND THE BEARINGS WERE FOUND CORRODED DUE TO DRIED SALINE. THE BEARINGS, SEALS, MOTOR AND CABLE WERE ALL REPLACED. THE UNIT WAS THEN TESTED AND MET ALL SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    EVENT DATE WAS (B)(6) 2013. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013 INDICATED THAT THIS WAS DETECTED DURING A NORMAL ROUTINE TESTING OF THE UNIT. THE UNIT HEATED UP WITHIN A FEW SECONDS OF USE. THERE WAS NO USER OR PATIENT IMPACT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VISAO HANDPIECE WAS OVERHEATING NEAR BURR GUIDE. THERE WAS NO REPORTED PATIENT IMPACT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VISAO HANDPIECE WAS OVERHEATING NEAR THE BURR GUIDE. THERE WAS NO REPORTED PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013 INDICATED THAT THIS WAS DETECTED DURING A NORMAL ROUTINE TESTING OF THE UNIT. THE UNIT HEATED UP WITHIN A FEW SECONDS OF USE. THERE WAS NO USER OR PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147552 DRILL 3334800 VISAO 80K HANDPIECE DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL MEDTRONIC XOMED, INC. 3334800 47007600

    Patients

    Seq Age Sex Outcome Treatment
    1