BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LHE CURVED SPATULA TIP

    MDR report key: 1813777 · Received August 18, 2010

    Report

    Report Number
    1717344-2010-00569
    Event Type
    Malfunction
    Date Received
    August 18, 2010
    Date of Event
    July 15, 2010
    Report Date
    July 27, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE EVALUATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ELECTRICAL LEAKAGE OCCURRED FROM THE SHAFT. THE DEVICE WAS ACTIVATED AND THE INSULATION ON THE EDGE OF THE SHAFT BECAME DAMAGED. THE PATIENT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LHE CURVED SPATULA TIP ELECTROSURGICAL ACCESSORY GEI COVIDIEN LP (VALLEYLAB) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK