BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH ETS45 ENDOSCOPIC LINEAR CUTTER - 2.5 MM -

    MDR report key: 642712 · Received October 21, 2005

    Report

    Report Number
    1527736-2005-04944
    Event Type
    Injury
    Date Received
    October 21, 2005
    Date of Event
    October 12, 2005
    Report Date
    October 12, 2005
    Manufacturer
    ETHICON ENDO-SURGERY, INC.(CINCINNATI)
    Product Code
    KOG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITIONS AND WITH A CARTRIDGE LOADED IN THE DEVICE. THE CARTRIDGE WAS RETURNED PARTIALLY FIRED AND WAS NOTED TO HAVE A WEDGE BAND BYPASS AS THE RIGHT SIDE WAS FULLY FIRED AND THE LEFT SIDE WAS 1/3 FIRED. THE CARTRIDGE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE PAN LOCKOUT TAB AND WAS FOUND NORMAL. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST CARTRIDGE AND FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT AN DIFFICULTIES, THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS. 510(K) # IS K020779.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO DEVICES WERE USED DURING A GASTRIC BYPASS PROCEDURE. WHILE THE FIRST DEVICE WAS BEING USED, THE BOWEL WAS PUNCTURED WITH A 3 INCH HOLE. THE HOLE WAS SUTURED. THE SECOND DEVICE FIRED, STAPLED BUT DID NOT CUT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS45 ENDOSCOPIC LINEAR CUTTER - 2.5 MM - ENDO LINEAR CUTTERS - ETS45MM KOG ETHICON ENDO-SURGERY, INC.(CINCINNATI) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN