BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS HANDPIECE - VISAO

    MDR report key: 12738015 · Received November 2, 2021

    Report

    Report Number
    1045254-2021-00606
    Event Type
    Malfunction
    Date Received
    November 2, 2021
    Report Date
    November 2, 2021
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ERL
    UDI-DI
    00885074107332
    PMA / PMN Number
    K011321
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3334625, SERIAL/LOT #: N/A. PMA / 510(K) #: K983224. PRODUCT ID: 3334800 ANALYSIS FOUND THE HANDPIECE NOISY AND OVERHEATING. AFTER ONE MINUTE THE PRE-REPAIR TEMPERATURES WERE REAR 50.9 DEG C, MIDDLE 60.2 DEG C AND NOSE 51.4 DEGC. PRODUCT ID 3334625 DURING INSPECTION, IT WAS CONFIRMED THAT THE BEARING HAD DETERIORATED. THERE WAS OVERHEATING. AFTER ONE MINUTE THE PRE-REPAIR TEMPERATURE WAS 49.8 DEGC. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT THE DEVICES GENERATED HEAT DURING INTRA-OP. THERE IS NO PATIENT IMPACT REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE VISAO DRILL OVERHEATED WITH THE 3334625 BUR GUARD AT 49.8C AT ONE MINUTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1635912 XPS HANDPIECE - VISAO DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) I ERL MEDTRONIC XOMED INC. 3334800 73520500 00885074107332

    Patients

    Seq Age Sex Outcome Treatment
    1