BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAPOINT

    MDR report key: 563707 · Received January 5, 2005

    Report

    Report Number
    2210968-2005-00004
    Event Type
    Malfunction
    Date Received
    January 5, 2005
    Date of Event
    November 23, 2004
    Report Date
    December 14, 2004
    Manufacturer
    ETHICON, INC.
    Product Code
    JOS
    Removal / Correction Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ENDS OF THE CABLE MELTED DURING STERILIZATION. THE STERILIZATION SETTINGS USED WERE 132-135 CELSIUS AT 4 MINUTES IN A WRAPPED PRE VACUUM CYCLE USING A PLASTIC POUCH FOR WRAPPING. THERE WAS NO PT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSAPOINT HYSTEROSCOPE AND ACCESSORIES JOS ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN