BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTOME ST HOLSTER/CABLES

    MDR report key: 1831779 · Received November 30, 2007

    Report

    Report Number
    1527736-2007-08119
    Event Type
    Malfunction
    Date Received
    November 30, 2007
    Date of Event
    November 5, 2007
    Report Date
    November 7, 2007
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    KNW
    PMA / PMN Number
    K991980
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE HOLDER IS SHUDDERING AND THE CONTROL MODULE DISPLAYED AN ERROR MESSAGE THAT THE GREEN CABLE IS INVOLVED. NO FURTHER INFORMATION IS AVAILABLE. NO REPORTED PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MTOME ST HOLSTER/CABLES KNW ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1