BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REUSABLE PENCIL W/15FT CORD 50U

    MDR report key: 3043082 · Received March 13, 2013

    Report

    Report Number
    1717344-2013-00178
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Report Date
    February 25, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL OF THE INCIDENT DEVICE DID NOT CONFIRM THE CUSTOMER'S REPORT THAT THE SWITCH DID NOT WORK. INSPECTION FOUND THE COAG SWITCH DOME WAS FLATTENED AT THE CONTACT POINT OF THE ROCKER POSTS. THE DOME WAS INVERTED INTO THE SWITCHBASE AND CRACKED IN THE CENTER, CAUSING THE SWITCH TO MAKE CONSTANT CONTACT. THE PENCIL WAS CORRECTLY ASSEMBLED AND THERE WAS NO EVIDENCE OF ANY MANUFACTURING DEFECTS. THE NOTED DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING USED TO ACTIVATE THE BUTTON.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTED THAT THE SWITCH OF THE INSTRUMENT DID NOT WORK. NO PT INJURY OR HARM OCCURRED. EVAL OF THE INCIDENT DEVICE FOUND IT TO SELF-ACTIVATE IN THE COAG MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106267 REUSABLE PENCIL W/15FT CORD 50U REUSABLE ES ACCESSORY GEI COVIDIEN LP 232572X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK