BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR

    MDR report key: 774090 · Received August 23, 2006

    Report

    Report Number
    1527736-2006-04062
    Event Type
    Malfunction
    Date Received
    August 23, 2006
    Report Date
    August 7, 2006
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    GCJ
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SENT 08/23/2006 INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    THE DEVICE WAS RECEIVED AS A BLIND UNIT WITH A NOTE STATING DEVICE FAILED TO STAPLE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR GDW GCJ ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN