BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45MM STAPLE LINE -

    MDR report key: 1083042 · Received July 23, 2008

    Report

    Report Number
    1527736-2008-03875
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    May 23, 2008
    Report Date
    May 28, 2008
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 7/23/2008. EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH NO CARTRIDGE LOADED ON THE DEVICE, HOWEVER FOUR CARTRIDGES WERE RECEIVED INSIDE THE BAG, FULLY FIRED AND WITH NO DAMAGE TO THE LOCKOUT. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST CARTRIDGE AND IT FIRED, CUT AND FORMED ALL STAPLES AS INTENDED; HOWEVER, THE CUT WAS NOTED TO BE SLIGHTLY JAGGED DUE TO A DAMAGED KNIFE, THIS DAMAGE IS CONSISTENT WHEN THE DEVICE IS FIRED OVER AN ALREADY EXISTING STAPLE LINE, HARD OBJECT OR THICKER TISSUE THAN INDICATED. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A WEDGE RESECTION PROCEDURE, THE SITE BLED FROM THE SECOND DEBRIDED AREA. ADDITIONAL SUTURE WAS PERFORMED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1