BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABLATOR - S

    MDR report key: 1913680 · Received December 3, 2010

    Report

    Report Number
    3003604053-2010-00017
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    October 12, 2010
    Report Date
    November 5, 2010
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY ANDOVER MANUFACTURE
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED FOR EVALUATION.(B)(4)

    Description of Event or Problem · 1

    PATIENT FELT TINGLING WHILE THE (B)(4) WAS USED. THE PROBE WAS CHANGED TO (B)(4) TO FINISH SURGERY. AFTER THE PROCEDURE BURN LIKE REDNESS WAS FOUND ALONG THE PARAMETER OF THE GROUND PAD AND IN THE CENTER OF IT. CUSTOMER COULD NOT TELL WHETHER IT WAS CAUSED BY THE PROBE, GROUND PAD, OR GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABLATOR - S MONOPOLAR ABLATION PROBE, 2MM,60DEG GEI SMITH & NEPHEW ENDOSCOPY ANDOVER MANUFACTURE 7209652

    Patients

    Seq Age Sex Outcome Treatment
    1