BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN PENCIL

    MDR report key: 3170783 · Received May 22, 2013

    Report

    Report Number
    1717344-2013-00372
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    March 18, 2013
    Report Date
    May 1, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT PENCIL HAS NOT BEEN RECEIVED FOR EVALUATION. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE BEEN ASKED. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A LAPAROSCOPIC LIVER BIOPSY, THE PENCIL WAS LAYING ON THE PATIENT. THE SURGEON ACCIDENTALLY PUSHED THE FOOTPEDAL WHICH ACTIVATED THE PENCIL ON THE FIELD. THE PATIENT RECEIVED A MINOR BURN. THE BURN WAS STITCHED UP DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227383 UNKNOWN PENCIL UNKNOWN COVIDIEN PENCIL GEI COVIDIEN LP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR FORCEFXC GENERATOR, S/N UNK