BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISP PNCL W/HLSTR BULKPAK

    MDR report key: 1900068 · Received November 9, 2010

    Report

    Report Number
    1717344-2010-00801
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    January 1, 2010
    Report Date
    November 1, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SITE DISPOSED OF THE INCIDENT DEVICE DURING THE PROCEDURE BEFORE CALLING AND REPORTING TO THE SURGICAL KIT MFR. NO EVAL CAN BE PERFORMED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT UPON CONNECTING THE ELECTROSURGICAL PENCIL TO GENERATOR, THE PENCIL ACTIVATED WITHOUT PRESSING THE SWITCH. THE DEVICE WAS NEVER IN CONTACT WITH PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISP PNCL W/HLSTR BULKPAK ELECTROSURGICAL ACCESSORY GEI COVIDIEN LP (VALLEYLAB) 189142

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK