BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPC® HANDPIECE - INDIGO¿ DRILL

    MDR report key: 9389981 · Received November 28, 2019

    Report

    Report Number
    1045254-2019-00641
    Event Type
    Malfunction
    Date Received
    November 28, 2019
    Report Date
    November 28, 2019
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    HBE
    PMA / PMN Number
    K081475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 1845020, SERIAL/LOT #: (B)(4), UDI#: (B)(4); PRODUCT ID: 1845020, SERIAL/LOT #: (B)(4), UDI#: (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A HEALTHCARE PROVIDER (HCP) REPORTED THAT A HANDPIECE OVERHEATED DURING A TYMPANOPLASTY PROCEDURE. THERE WAS NO PATIENT OR STAFF IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1184049 IPC® HANDPIECE - INDIGO¿ DRILL DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MEDTRONIC XOMED INC. 1845000 209706185

    Patients

    Seq Age Sex Outcome Treatment
    1