BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTROSURGERY PROBE PLUS II

    MDR report key: 1210135 · Received October 20, 2008

    Report

    Report Number
    3005075853-2008-02468
    Event Type
    Malfunction
    Date Received
    October 20, 2008
    Date of Event
    January 1, 2008
    Report Date
    September 26, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GCJ
    PMA / PMN Number
    K912492
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    D4; H4, 6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO AN UNK PROCEDURE, THE END OF THE DEVICE WAS BENT AND THE CUSTOMER COULD NOT USE IT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE CASE WITH NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTROSURGERY PROBE PLUS II GCJ ETHICON ENDO-SURGERY, LLC NA E4KC0D

    Patients

    Seq Age Sex Outcome Treatment
    1