BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE ES ROCKER 756 SERIES

    MDR report key: 587868 · Received March 7, 2005

    Report

    Report Number
    587868
    Event Type
    Malfunction
    Date Received
    March 7, 2005
    Date of Event
    February 9, 2005
    Report Date
    March 7, 2005
    Manufacturer
    OLSEN MEDICAL
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PATIENT UNDERWENT A NEEDLE LOCALIZATION EXCISION OF LEFT BREAST MASS. DURING THE PROCEDURE WHILE USING THE ELECTROCAUTERY PENCIL, THE TIP BROKE OFF. THE TIP WAS RETRIEVED WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE ES ROCKER 756 SERIES OLSEN DISPOSABLE ES ROCKER 756 SERIES GEI OLSEN MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR