BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS LINEAR CUTTER RELOAD

    MDR report key: 3821182 · Received May 20, 2014

    Report

    Report Number
    3005075853-2014-03373
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    January 13, 2014
    Report Date
    January 31, 2014
    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
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THREE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WHAT IS MEANT BY ¿RELOAD PREFIRED¿? DID THE DEVICE DELIVER ANY STAPLES? IF YES, WERE THE STAPLES FORMED PROPERLY? WAS THE STAPLE LINE COMPLETE? DID THE DEVICE DELIVER A CUT LINE? IF YES, WAS THE CUT LINE COMPLETE? WERE ANY ISSUES NOTED WITH THE CUT LINE SUCH AS IRREGULAR CUT, JAGGED CUT, ETC? ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? WHAT WAS THE PRODUCT CODE AND LOT/BATCH NUMBER FOR THE STAPLER USED WITH THE TR45W CARTRIDGE? WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? THE ANALYSIS RESULTS FOUND THAT THE CARTRIDGE RELOAD WAS RETURNED IN GOOD CONDITIONS. THE CARTRIDGE WAS RETURNED PARTIALLY FIRED 1/10 AND THE LOCKOUT WAS FOUND DAMAGED. THE DAMAGE TO THE RELOAD LOCKOUT SPRING IS CONSISTENT WITH DAMAGE OBSERVED WHEN THE FIRING CYCLE IS STARTED, INTERRUPTED, RELEASED, AND RESTARTED. WHEN FIRING THE DEVICE MAKE SURE THAT THE FIRING STROKE IS COMPLETED. ONCE THE FIRING CYCLE HAS BEEN INITIATED, IT MUST BE COMPLETED. IF RE-INITIATION OF FIRING IS RESUMED, THE DEVICE WILL LOCKOUT. FIRING THROUGH THE LOCKOUT MECHANISM WILL BREAK THE DEVICE. IN ADDITION THE CARTRIDGE DECK WAS FOUND DAMAGED WHERE THE FIRING STOPPED. THE DAMAGED FOUND ON THE CARTRIDGE DECK IS CONSISTENT WITH DAMAGED CAUSED WHEN THE DEVICE IS CLAMPED OVER A HARD OBJECT. WHEN THIS HAPPENS THE CARTRIDGE GETS INDENTED THEREFORE THERE IS NOT ENOUGH SPACE FOR THE WEDGE PUSHING THE DRIVER TO CONTINUE ITS RUN. IF RESISTANCE IS FELT, STOP AND REPLACE THE CARTRIDGE. PLEASE REFERENCE INSTRUCTIONS FOR USE FOR ADDITIONAL INSTRUCTIONS. THE RETURNED CARTRIDGE COULD NOT BE TESTED DUE TO ITS CONDITION. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN FIRING THE LAST WHITE RELOAD, THE RELOAD PRE-FIRED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298905 ETS LINEAR CUTTER RELOAD STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4DG4C

    Patients

    Seq Age Sex Outcome Treatment
    1