BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS45 ENDOSCOPIC LINEAR CUTTER - 2.5 MM - VASCULAR/THIN

    MDR report key: 1170296 · Received September 12, 2008

    Report

    Report Number
    3005075853-2008-01661
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Date of Event
    July 30, 2008
    Report Date
    August 1, 2008
    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
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DAMAGED FIRING MECHANISM. EVALUATION SUMMARY. TWO DEVICES (A-B) WERE RETURNED FOR ANALYSIS. DEVICE WAS RECEIVED WITH THE FIRING MECHANISM DAMAGED AND WITH A RELOAD IN THE DEVICE. THE RELOAD WAS RECEIVED PARTIALLY FIRED AND WITH NO DAMAGE TO THE CARTRIDGE LOCKOUT SPRING. THE RETURNED DEVICE WAS FOUND TO BE NON FUNCTIONAL AS THE FIRING MECHANISM WAS NOTED TO BE DAMAGED. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE FIRING TRIGGER TEETH WERE FOUND DAMAGED, IN ADDITION, THE LEFT SHROUD PINION AXLE SUPPORT WAS FOUND BROKEN. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT FGQA. DEVICE B WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A RELOAD IN THE DEVICE. THE RELOAD WAS RECEIVED PARTIALLY FIRED AND WITH NO DAMAGED TO THE SPRING LOCKOUT; IT IS POSSIBLE THAT THE DEVICE'S FIRING STROKE WAS INTERRUPTED. THE RETURNED DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD 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 SHAPED. DEVICE B ADDITIONAL INFORMATION: BATCH #E5NV3A. EXPIRATION DATE: 05/2013. MANUFACTURING DATE: 06/2008.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN LAVH PROCEDURE, THERE WAS AN ISSUE WITH THE TWO DEVICES. A THIRD DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS45 ENDOSCOPIC LINEAR CUTTER - 2.5 MM - VASCULAR/THIN GDW ETHICON ENDO-SURGERY, LLC NA E4L533

    Patients

    Seq Age Sex Outcome Treatment
    1