BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPC HANDPIECE - INDIGO DRILL

    MDR report key: 11782859 · Received May 6, 2021

    Report

    Report Number
    1045254-2021-00224
    Event Type
    Malfunction
    Date Received
    May 6, 2021
    Date of Event
    March 30, 2021
    Report Date
    May 6, 2021
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    HBE
    UDI-DI
    00613994933713
    PMA / PMN Number
    K081475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS FOUND THAT THE COLLET WAS OVERHEATING. UPON PRE-CHECK, TEMPERATURE AT ONE MINUTE WAS 85.1°F ON MOTOR AND 119.5°F ON COLLET. HAND PIECE WAS TOO DIRTY AND BEARING OF THE COLLET WAS CORRODED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS OVERHEATING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683149 IPC HANDPIECE - INDIGO DRILL DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MEDTRONIC XOMED INC. 1845000 215359015 00613994933713

    Patients

    Seq Age Sex Outcome Treatment
    1