BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKEETER ULTRA-LITE

    MDR report key: 2140646 · Received June 23, 2011

    Report

    Report Number
    2140646
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 2011
    Manufacturer
    MEDTRONIC XOMED
    Product Code
    ERL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE WAS UNDERWAY AND A TYMPANOSTOMY HAD BEEN PERFORMED. THE MEDTRONIC SKEETER ULTRA-LITE DRILL WAS HANDED TO THE SURGEON WHO HAD ELECTED TO DO A STAPEDECTOMY. THE DRILL TIP CRIMPED SHUT AND WAS UNABLE TO PASS THE BIT. THE PROCEDURE HAD TO BE ABORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SKEETER ULTRA-LITE DRILL, SURGICAL, ENT ERL MEDTRONIC XOMED 30-55601 *

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR