BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPC® HANDPIECE ATTACHMENT - INDIGO¿ DRILL

    MDR report key: 4727538 · Received April 24, 2015

    Report

    Report Number
    1045254-2015-00131
    Event Type
    Malfunction
    Date Received
    April 24, 2015
    Date of Event
    March 16, 2015
    Report Date
    March 31, 2015
    Manufacturer
    MEDTRONIC XOMED, INC
    Product Code
    HBE
    PMA / PMN Number
    K081475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT PRODUCTS: DRILL: 1845000 INDIGO HIGH SPEED OTOLOGIC, 510K: K081475, SERIAL # (B)(4), LOT# 208309894, MFR DATE: 2014-05-08. ATTACHMENT: 1845010 INDIGO OTOL STRAIGHT, 510K: K081475, SERIAL# (B)(4), LOT# 207155377, MFR DATE 2013-08-21. (B)(4).

    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 THE DEVICE WAS GETTING HOT AND HAD TO USE A DAMP TOWEL TO WRAP AROUND THE DRILL WHILE BEING USED. THERE WAS NO REPORTED PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271906 IPC® HANDPIECE ATTACHMENT - INDIGO¿ DRILL DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MEDTRONIC XOMED, INC 1845020 207305240

    Patients

    Seq Age Sex Outcome Treatment
    1