BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER 45MM STAPLE LINE 3.5MM

    MDR report key: 1822317 · Received December 6, 2007

    Report

    Report Number
    1527736-2007-08315
    Event Type
    Malfunction
    Date Received
    December 6, 2007
    Report Date
    October 24, 2007
    Manufacturer
    ETHICON ENDO-SURGERY, INC (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: TWO DEVICES (A-B) WERE RECEIVED FOR ANALYSIS. DEVICE A WAS RETURNED IN GOOD VISUAL CONDITION 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 1/8 FIRED. THE CARTRIDGE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE SPRING CARTRIDGE LOCKOUT 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 ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. DEVICE B WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A CARTRIDGE LOADED IN THE DEVICE. THE CARTRIDGE WAS RECEIVED PARTIALLY FIRED AND WITH NO DAMAGED TO THE SPRING LOCKOUT TAB; IT IS POSSIBLE THAT THE DEVICE'S FIRING STROKE WAS INTERRUPTED. THE RETURNED DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST CARTRIDGE AND IT FIRED, CUT, AND ALL THE STAPLES FORMED AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICES WERE USED DURING AN UNKNOWN PROCEDURE. THE DEVICES MISFIRED. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER 45MM STAPLE LINE 3.5MM GDW ETHICON ENDO-SURGERY, INC (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1