BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDGE CT PEN ROCKER HLSTER GAYLD

    MDR report key: 2913852 · Received December 5, 2012

    Report

    Report Number
    1717344-2012-01204
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Report Date
    November 5, 2012
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SITE INDICATED THE INCIDENT SAMPLE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAIN, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CAUTERY FLAMED UP DURING A PROCEDURE. THERE WAS NO INJURY TO THE PATIENT. THE INCIDENT DEVICE IS NOT AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDGE CT PEN ROCKER HLSTER GAYLD ES ACCESSORY - NON STERILE GEI COVIDIEN LP 233136X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK