BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWITCH PEN

    MDR report key: 4298060 · Received November 21, 2014

    Report

    Report Number
    1530493-2014-00004
    Event Type
    Malfunction
    Date Received
    November 21, 2014
    Date of Event
    October 12, 2014
    Report Date
    November 19, 2014
    Manufacturer
    OLSEN MEDICAL
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING A PROCEDURE, SUDDENLY THE TIP TOOK FIRE, NO PATIENT INVOLVEMENT, NO PATIENT INJURY. OLSEN 6" (15.2CM) HAND ACTIVATED, BUTTON SWITCH PEN (WHITE) WITH ATTACHED 10' (3.0M) CORD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758265 SWITCH PEN OLSEN SWITCH PEN GEI OLSEN MEDICAL 75530 030896

    Patients

    Seq Age Sex Outcome Treatment
    1 NA