BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDGE INSUL.COATED BLADE

    MDR report key: 3970200 · Received April 29, 2014

    Report

    Report Number
    1717344-2014-00373
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 14, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE WAS DISCARDED BY THE SITE AND IS NOT AVAILABLE FOR EVALUATION. 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 THE PROCEDURE, THE CLEAR PLASTIC INNER SHEATH ON THE CAUTERY TIP DETACHED FROM THE OUTER BLUE PLASTIC SHEATH. NOTHING FELL INTO THE PATIENT CAVITY. THERE WAS NO INJURY TO THE PATIENT. ANOTHER DEVICE WAS USED WITHOUT ANY FURTHER CONSEQUENCE. THE INCIDENT DEVICE WAS DISCARDED BY THE SITE AND IS NOT AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256057 EDGE INSUL.COATED BLADE ES ACCESSORY GEI COVIDIEN LP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK