BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THUNDERBEAT HANDPIECE (TB-0535FC)

    MDR report key: 4888306 · Received June 26, 2015

    Report

    Report Number
    MW5043457
    Event Type
    Injury
    Date Received
    June 26, 2015
    Date of Event
    June 24, 2015
    Report Date
    June 26, 2015
    Manufacturer
    OLYMPUS
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE USING THE OLYMPUS THUNDERBEAT HANDPIECE 5MM, 35CM (REF. TB-0535FC) (LOT MK942302), DURING A SURGICAL PROCEDURE, THE OSCILLATING TIP BROKE OFF IN THE PATIENT. THE ENTIRE TIP WAS RETRIEVED. DIAGNOSIS OR REASON FOR USE: USED DURING LAPAROSCOPIC SURGERY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415044 THUNDERBEAT HANDPIECE (TB-0535FC) THUNDERBEAT HANDPIECE GEI OLYMPUS TB-0535FC MK942302

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention