BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUTTONSWITCH PENCIL

    MDR report key: 3063424 · Received March 28, 2013

    Report

    Report Number
    1717344-2013-00229
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 18, 2013
    Manufacturer
    COVIDIEN LP, FORMERLY KNOW AS VALLEYLAB, A DIVISON
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SITE REPORTED THE INCIDENT SAMPLE IS NOT BEING RETURNED FOR EVAL. ADD'L QUESTIONS IN REGARD TO THE INCIDENT HAVE BEEN ASKED. IF THE SAMPLE IS RETURNED, OR IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A SCRUB TECH DIDN'T INSERT THE ELECTRODE ALL THE WAY INTO THE PENCIL BODY, THUS RESULTING IN CURRENT LEAKING AT THE DISTAL TIP OF THE HANDLE WHERE THE ELECTRODE IS INSERTED. THIS CURRENT CAUSED A MINOR BURN TO THE PATIENT'S SKIN. THE AREA OF SKIN THAT WAS BURNED WAS AT THE SURGICAL SITE, SO THE SURGEON CUT OUT THE BURNED SKIN BEFORE CLOSING THE PATIENT. THE INCIDENT DEVICE IS NOT BEING RETURNED FOR EVAL. NO ADD'L INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127351 BUTTONSWITCH PENCIL ES ACCESSORY GEI COVIDIEN LP, FORMERLY KNOW AS VALLEYLAB, A DIVISON

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK E1455 COATED ELECTRODE: L/N UNKNOWN