BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUTTING LOOP

    MDR report key: 5324260 · Received September 24, 2004

    Report

    Report Number
    1519132-2004-00062
    Event Type
    Malfunction
    Date Received
    September 24, 2004
    Date of Event
    August 24, 2004
    Report Date
    September 24, 2004
    Manufacturer
    ACMI NORWALK
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ACMI CONFIRMS CUSTOMER'S COMPLAINT AND DAMAGE TO SCOPE. THE CAUSE OF THE ISSUE IS DUE TO CUSTOMER MISUSE. THE CUSTOMER USED A 0 DEGREE SCOPE TO PERFORM A RESECTION. THE INSTRUCTIONS FOR USE, 99-1031 REV E, FOR THE EIWE WORKING ELEMENT CLEARLY STATES IN SECTION 3.1 TO ONLY USE THE 12 DEGREE OR 30 DEGREE TELESCOPE FOR RESECTION. REFERENCE: (B)(4).

    Description of Event or Problem · 1

    THE CUTTING LOOP STARTED TO BREAK IN SURGERY SO THE CUSTOMER SWITCHED THE CUTTING LOOP AND THE M3-0 SCOPE AND THE NEW LOOP STARTED TO ARC AND IT BLEW OUT OF THE SIDE OF THE SHEATH AND MELTED THE SCOPE DOWN TO THE OPTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUTTING LOOP 500 KNS ACMI NORWALK MLE-24-012 BE3769 BF6481

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK