BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** ETS45

    MDR report key: 2082054 · Received May 9, 2011

    Report

    Report Number
    3005075853-2011-01862
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Report Date
    April 13, 2011
    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
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THE SURGEON SAW A LOT OF STAPLE LINES WHICH WERE "DODGY" AND SEVERAL STAPLES FALLING OFF FROM NORMAL STAPLE LINES. IT APPEARED THAT THE INNERMOST STAPLE LINE ALMOST IS NOT INCLUDED IN THE TISSUE OR RIPPED OUT WHEN CUTTING. THE CUSTOMER DISPOSED OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH** ETS45 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1