BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER

    MDR report key: 725987 · Received June 8, 2006

    Report

    Report Number
    1527736-2006-02636
    Event Type
    Malfunction
    Date Received
    June 8, 2006
    Date of Event
    March 22, 2006
    Report Date
    March 23, 2006
    Manufacturer
    ETHICON ENDO SURGERY, INC.(CINCINNATI)
    Product Code
    GCJ
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    H6: 100=DAMAGED CRIMP ASSEMBLY EVALUATION SUMMARY: BASED ON THE ANALYSIS FINDING OF DAMAGED FLEXNECK, THIS FILE IS REPORTABLE. THE DEVICE WAS RETURNED WITH THE FLEXNECK DAMAGED AT THE H-CRIMP AREA AND WITH NO CARTRIDGE PRESENT. EVEN THOUGH THE FLEXNECK WAS DAMAGED IT WAS POSSIBLE TO FIRED THE DEVICE DURING THE ANALYSIS AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MFG PROCESS. 510(K) NUMBER K020779.

    Description of Event or Problem · 1

    DURING A LAP COLON PROCEDURE, THE JAWS WERE NOT ALIGNED WHEN CLOSED DOWN, IT WAS LOOSE. PULLED OUT OF FIELD BEFORE FIRED IN PT. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER GDW GCJ ETHICON ENDO SURGERY, INC.(CINCINNATI) NA C4D18U

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN