BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPC® HANDPIECE - INDIGO¿ DRILL

    MDR report key: 4623643 · Received March 23, 2015

    Report

    Report Number
    1045254-2015-00088
    Event Type
    Malfunction
    Date Received
    March 23, 2015
    Date of Event
    February 26, 2015
    Report Date
    February 26, 2015
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    HBE
    PMA / PMN Number
    K081475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT PRODUCT: ATTACHMENT 1845010 INDIGO OTOL STRAIGHT, 510K: K081475 , LOT NUMBER AND MANUFACTURED DATE UNKNOWN. (B)(4). THE PRODUCT ANALYSIS CANNOT BE COMPLETED AS THE DEVICES WILL NOT BE RETURNED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ¿DURING THE OPERATION FOR ARTIFICIAL INNER EAR, THE INDIGO DRILL GENERATED HEAT WHEN THE STRAIGHT ATTACHMENT WAS USED TOGETHER, WHILE NO PROBLEM WAS NOTED WHEN THE ANGLED ATTACHMENT WAS USED. THERE IS A SMALL POSSIBILITY THAT THE DEVICE WAS NOT LOCKED. THE SURGERY WAS PERFORMED WITH NO ADVERSE EFFECT, BUT IT WAS EXTENDED FOR A FEW MINUTES TO COMPLETE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192955 IPC® HANDPIECE - INDIGO¿ DRILL DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MEDTRONIC XOMED INC. 1845000

    Patients

    Seq Age Sex Outcome Treatment
    1