BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 1924011 · Received December 14, 2010

    Report

    Report Number
    1056128-2010-00096
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Report Date
    December 14, 2010
    Manufacturer
    ASCENT
    Product Code
    NUJ
    PMA / PMN Number
    K052690
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY ASCENT. A VISUAL EXAMINATION REVEALED THAT THE DEVICE HAD A GAP IN BETWEEN THE JAWS. FUNCTION TESTING WAS PERFORMED AND THE DEVICE FAILED THE CUT TEST. A REVIEW OF THE LOT CONTROL SHEET FOR THE REPORTED DEVICE SERIAL NUMBER INDICATED THAT THE INSTRUMENT PASSED ALL APPLICABLE TESTS AND INSPECTIONS PRIOR TO RELEASE. ENHANCEMENTS WERE MADE ON ASCENT'S INLINE INSPECTION PROCESS AFTER THE COMPLAINT DEVICE'S PRODUCTION DATE. ASCENT'S INSTRUCTIONS FOR USE STATE: "BEFORE ENGAGING CUTTING BLADE, ENSURE TISSUE IS FULLY DESICCATED." "TO PREVENT TISSUE FROM STICKING TO THE FORCEPS, DISCONTINUE POWER APPLICATION WHEN THE TISSUE HAS BEEN DESICCATED AND/OR FLUSH PROCEDURE SITE WITH STERILE SALINE TO KEEP TISSUE MOIST." "USE A 4" X 4" GAUZE PAD SATURATED WITH SALINE SOLUTION TO CLEAN THE COAGULATING SURFACES BY REMOVING THE DEBRIS. KEEP THE CUTTING BLADE RETRACTED WHILE CLEANING. KEEP THE JAWS FREE OF DEBRIS TO ENSURE OPTIMUM PERFORMANCE." THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BIPOLAR CUTTING FORCEPS "DID NOT CUT." THE DEVICE WAS REPLACED WITH A LIGASURE DEVICE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A NUJ NUJ ASCENT 920005PK 921941

    Patients

    Seq Age Sex Outcome Treatment
    1