BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH ETS45

    MDR report key: 1890053 · Received November 2, 2010

    Report

    Report Number
    3005075853-2010-06222
    Event Type
    Injury
    Date Received
    November 2, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 5, 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
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 11/02/2010. EVAL SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE ETS45 DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED FULLY FIRED. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE DEVICE FIRED AND CUT WITHOUT DIFFICULTIES, THE STAPLE LINE WAS COMPLETE, THE CUT LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE (USING THE OMEGA LOOP TECHNIQUE), THE SURGEON OBSERVED THE STAPLE LINES WERE NICE AND DRY MAKING THE POUCH AND ALSO AFTER DIVIDING THE INTESTINE. AFTER DIVISION OF THE JEJUNUM, THE SURGEON RETURNED TO THE GJ ANASTOMOSIS FOR THE LEAK TEST. THE SURGEON FOUND THAT THE STAPLE LINES HAD STARTED TO BLEED AND HE NEEDED TO PLACE SEVERAL SUTURES FOR HEMOSTASIS. HE ALSO INSPECTED THE TRANSECTION OF THE JEJUNUM, AND THAT STAPLE LINE HAD ALSO STARTED TO BLEED THROUGH THE STAPLES AND HE USED CLIPS TO GET HEMOSTASIS. THE CONDITION OF THE PT IMMEDIATELY FOLLOWING THE EVENT WAS STABLE. THE CARTRIDGE FOR TRANS OF THE JJ IS WHITE - STILL IN THE JAWS OF THE DEVICE. PT DID NOT EXPERIENCE HOSPITALIZATION LONGER THAN EXPECTED; HOWEVER, PT WAS IN THE OPERATING ROOM AFTER THE PLANNED SURGERY FOR A F/U EXAM VIA SCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS45 GDW STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC NA G4TF21

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other TR45W, LOT # G4T826| 2ND RELOAD PRODUCT # 6R45B