BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*45 ENDOPATH** STAPLER

    MDR report key: 3053405 · Received April 11, 2013

    Report

    Report Number
    3005075853-2013-01744
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 21, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4) = PREMATURE SLED MOVEMENT THE ANALYSIS RESULTS SHOWED THAT TWO ECR60B RELOADS WERE RECEIVED PARTIALLY FIRED (B)(6). IT IS POSSIBLE THAT WHILE LOADING THE RELOAD, THE CARTRIDGE WAS PUSHED FARTHER BACK THAN THE CARTRIDGE ALIGNMENT STOP WINDOWS RESULTING IN THE KNIFE PUSHING THE ONE PIECE SLED FORWARD AND LOCKING THE CARTRIDGE. THE RETURNED RELOADS WERE RESET AND LOADED INTO A TEST DEVICE. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION AND ACHIEVED ITS COMPLETE STROKE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. SECOND CARTRIDGE BATCH: J5GV0L. MANUFACTURING DATE: 06/02/2012; PRODUCT EXP. DATE: 05/02/2017.

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO HAVE DEVICE RETURNED. DEVICE LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE NOT WELL FORMED B SHAPED STAPLES. NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156614 ECHELON*45 ENDOPATH** STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1