BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELOAD-CURVED STAPLER

    MDR report key: 3900029 · Received June 27, 2014

    Report

    Report Number
    3005075853-2014-04476
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    May 29, 2014
    Report Date
    June 3, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K040038
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INCOMPLETE FIRING CYCLE. THE ANALYSIS RESULTS SHOWED THAT THE CR40B RELOAD WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH ONLY 15 STAPLES PRESENT, WITH THE WASHER UNCUT AND WITH THE KNIFE RECESS BELOW THE RELOAD DECK. THE STAPLES WERE NOTED TO BE PROTRUDING; THIS CONDITION IS CONSISTENT WITH THE DEVICE BEING PARTIALLY ACTIVATED. DO NOT FIRE THE INSTRUMENT UNLESS THE CLOSURE TRIGGER IS PROPERLY LATCHED AGAINST THE HANDLE. THE FIRING TRIGGER MUST BE PULLED BACK COMPLETELY AGAINST THE CLOSURE TRIGGER TO PROPERLY FIRE THE INSTRUMENT. IN ADDITION, IF THE FIRING SEQUENCE IS NOT COMPLETE, YOU COULD DEPLOY THE STAPLES WITHOUT CUTTING THE WASHER AND FORMING THE STAPLES. PLEASE REFERENCE INSTRUCTIONS FOR USE FOR ADDITIONAL INFORMATION. NO FUNCTIONAL TEST WAS PERFORMED DUE TO THE CONDITION OF THE RELOAD. A BATCH RECORD REVIEW WAS PERFORMED AND THE BATCH HAD NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP LOW ANTERIOR RESECTION, AN INSTRUMENT LOADING THE REPORTED CR40B COULD NOT BE FIRED AT THE 2ND FIRING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377960 RELOAD-CURVED STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA J4AJ8Z

    Patients

    Seq Age Sex Outcome Treatment
    1