BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 2032867 · Received March 29, 2011

    Report

    Report Number
    1056128-2011-00015
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 2011
    Manufacturer
    ASCENT
    Product Code
    NUJ
    PMA / PMN Number
    K052690
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RETURNED TO ASCENT IN A GENERIC BAG. A VISUAL EXAMINATION OF THE DEVICE CONFIRMED DAMAGE TO THE ELECTRICAL CORD NEAR THE HANDLE. SINCE THE DEVICE WAS RETURNED TO ASCENT IN AN OPENED PACKAGE IT IS UNKNOWN WHEN THE DAMAGE OCCURRED. THE MOST PROBABLE CAUSES FOR THE DAMAGE OCCURRED WHEN THE DEVICE WAS SHIPPED TO ASCENT FOR REPROCESSING OR DURING PROCEDURAL SET UP AT THE COMPLAINT FACILITY. ALTHOUGH THE DEVICE HISTORY RECORD FOR THE COMPLAINT DEVICE SHOWED THE DEVICE PASSED ALL VISUAL AND FUNCTIONAL TESTING BEFORE LEAVING ASCENT, RE-TRAINING WAS CONDUCTED ON THE INSPECTION PROCEDURES. 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 WHEN THE BIPOLAR CUTTING FORCEPS WERE OPENED UP FOR THE PROCEDURE, THERE WAS A RIP IN THE COVERING OF THE ELECTRIC CORD NEAR THE HANDLE OF THE DEVICE EXPOSING THE WIRES. THE DEVICE WAS NOT USED SO THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A NUJ NUJ ASCENT 920005K 1085580

    Patients

    Seq Age Sex Outcome Treatment
    1