BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IPC® HANDPIECE - INDIGO¿ DRILL

    MDR report key: 8493123 · Received April 8, 2019

    Report

    Report Number
    1045254-2019-00173
    Event Type
    Injury
    Date Received
    April 8, 2019
    Date of Event
    March 11, 2019
    Report Date
    May 8, 2019
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    HBE
    UDI-DI
    00613994933713
    PMA / PMN Number
    K081475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THERE WAS NO FAULT IN THE HANDPIECE BUT THE ATTACHMENT WAS NOISY AND CORRODED AND THE LOCKING MECHANISM WAS JAMMED. CONCOMITANT MEDICAL PRODUCTS: OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 1845020, SERIAL/LOT #: (B)(4)/206308289, UDI #: (B)(4).. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A HEALTH CARE PROVIDER (HCP) REPORTED THAT DURING THE PROCEDURE A HANDPIECE AND AN ATTACHMENT OVERHEATED AND BURNED THE SURGEON'S HAND. THERE WAS NO PATIENT IMPACT.

    Description of Event or Problem · 1

    ON FOLLOW UP, IT WAS CONFIRMED THAT THE SURGEON DID NOT GET BURNT BUT WOULD HAVE BEEN BURNT WITH CONTINUED USE OF THE DEVICE. THERE WAS NO PATIENT IMPACT. IT WAS ALSO CONFIRMED THAT IT WAS THE HANDPIECE THAT WAS GETTING HOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284772 IPC® HANDPIECE - INDIGO¿ DRILL DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MEDTRONIC XOMED INC. 1845000 210835022 00613994933713

    Patients

    Seq Age Sex Outcome Treatment
    1 Other