BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GSU 2 EXTENDER 28CM

    MDR report key: 2429172 · Received December 21, 2011

    Report

    Report Number
    1717344-2011-01189
    Event Type
    Malfunction
    Date Received
    December 21, 2011
    Date of Event
    November 16, 2011
    Report Date
    November 22, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVAL. WHEN THE DEVICE EVAL IS COMPLETE, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING THE PROCEDURE, A PART OF THE TIP COVER WAS BROKEN. THEY CHANGED TO ANOTHER DEVICE AND COMPLETED THE PROCEDURE WITHOUT ANY FURTHER PROBLEMS. THERE WAS NO PT INJURY. INITIAL EVAL OF THE INCIDENT DEVICE FOUND THE INSULATION HAD MELTED AT THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GSU 2 EXTENDER 28CM ES ACCESSORY GEI COVIDIEN LP (VALLEYLAB) 205362X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK