BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS FLEX45

    MDR report key: 1941098 · Received December 8, 2010

    Report

    Report Number
    3005075853-2010-06912
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 24, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FIRING TRIGGER TEETH. EVAL SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE ATW45 DEVICE WAS RECEIVED WITH THE FIRING MECHANISM DAMAGED AND WITH TWO RELOADS PRESENT. RELOAD (A) WAS RECEIVED FULLY FIRED AND WITH CARTRIDGE LOCKOUT SPRING DAMAGED; RELOAD (B) WAS RECEIVED UNFIRED. THE DAMAGE TO THE RELOAD LOCKOUT SPRING IS CONSISTENT WITH DAMAGE OBSERVED WHEN ATTEMPTING TO FIRE AN ALREADY SPENT CARTRIDGE. THE RELOAD IS DESIGNED TO LOCK OUT AFTER A PARTIAL OR COMPLETE FIRE TO AVOID RE FIRING A PARTIALLY OR FULLY SPENT RELOAD. FIRING THROUGH THE LOCKOUT MECHANISM CAN BREAK THE DEVICE. FOR MORE INFO PLEASE REFER TO THE INSTRUCTIONS FOR USE. NO FUNCTIONAL TEST COULD BE PERFORMED WITH THE RETURNED INSTRUMENT DUE TO ITS CONDITION. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE FIRING TRIGGER TEETH WERE FOUND BROKEN. HOWEVER, RELOAD (B) WAS TESTED FOR FUNCTIONALITY WITH A TEST INSTRUMENT 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 BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MFG PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROTOMY PROCEDURE, THE DEVICE REMAINED BLOCKED AND COULD NOT WORK, THE DEVICE WOULD NOT FIRE. THE PROCEDURE WAS FINALLY PERFORMED WITH A COMPETITOR DEVICE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS FLEX45 GDW STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC NA G4RJ3W

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK