BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LONG 45 ENDOCUTTER

    MDR report key: 1902560 · Received November 18, 2010

    Report

    Report Number
    3005075853-2010-06587
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 28, 2010
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THE DEVICE PRODUCED AN INCOMPLETE STAPLE LINE AND A COMPLETE CUT LINE. THEN THE RELOAD FELL OUT OF THE DEVICE. THE SURGEON USED THIS AREA AS THE OTOMY PART OF THE PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LONG 45 ENDOCUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1