BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1058697 · Received June 3, 2008

    Report

    Report Number
    1527736-2008-03431
    Event Type
    Injury
    Date Received
    June 3, 2008
    Date of Event
    May 12, 2008
    Report Date
    May 14, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 06/03/2008. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE COULD NOT BE FIRED. IT DID NOT STAPLE OR CUT. BECAUSE THERE WAS NO SIMILAR DEVICE FOR BACKUP, THE PROCEDURE WAS CONVERTED TO OPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45MM STAPLE LINE-3.5M GDW ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA T4XK9U

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention