BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45 MM STAPLE LINE-3.5

    MDR report key: 1122030 · Received August 14, 2008

    Report

    Report Number
    3005075853-2008-01202
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    July 22, 2008
    Report Date
    July 31, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    D4, H4: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE DEVICE WAS FIRED WITH A RELOAD ON A COLON CASE AND IT DELIVERED AN INCOMPLETE STAPLE LINE. THE CASE WAS COMPLETED WITH ANOTHER DEVICE. THE PT IS CURRENTLY STABLE. THE DEVICE IS NOT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45 MM STAPLE LINE-3.5 GDW ETHICON ENDO-SURGERY, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1