BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWER SYSTEM 2000

    MDR report key: 263492 · Received February 16, 2000

    Report

    Report Number
    263492
    Event Type
    Injury
    Date Received
    February 16, 2000
    Date of Event
    February 1, 2000
    Report Date
    February 15, 2000
    Manufacturer
    XOMED SURGICAL PRODUCT INC.
    Product Code
    DZI
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING MASTOID SURGERY, SKEETER DRILL NOT FUNCTIONING, SURGICAL INCISION CLOSED AND SURGERY CANCELLED. MFR/REP NOTIFIED. DRILL BIT WOULD NOT ACTIVATE DUE TO MALFUNCTION OF MOTOR OUTLET. REP RETRIEVED HANDLE AND DRILL BIT RETURNED TO XOMED, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWER SYSTEM 2000 SKEETER DRILL DZI XOMED SURGICAL PRODUCT INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization