BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LONG 45 ENDOCUTTER

    MDR report key: 1780345 · Received July 27, 2010

    Report

    Report Number
    3005075853-2010-04254
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 29, 2010
    Report Date
    June 30, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE WAS PERFORMED AND THE PROCEDURE WENT WELL. THE STAPLES WERE FORMED PROPERLY AND A LEAK TEST WAS PERFORMED DURING THE PROCEDURE. THE NEXT DAY, THE PATIENT WAS EXHIBITING SOME PROBLEMS. THE PATIENT WAS TAKEN IN FOR SOME DIAGNOSTIC TESTING AND IT WAS FOUND THAT THE CROTCH OF THE JEJUNOSTOMY ANASTOMOSIS WAS LEAKING. THE PATIENT WAS TAKEN BACK INTO THE OPERATING ROOM AND SUTURES WERE USED TO COMPLETE THE STAPLE LINE LEAK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention TR45B