BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ECH FLEX 60MM

    MDR report key: 3153135 · Received June 8, 2013

    Report

    Report Number
    3005075853-2013-02883
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 16, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: HOW MUCH BLOOD LOSS? UNK, THE PATIENT DID NOT RECEIVE A BLOOD TRANSFUSION WHAT ADVERSE EVENT HAPPENED TO THE PATIENT? AS PER THE CASE FORM: THERE WAS NO ADVERSE EVENT REPORTED. SURGEON DID OVER-SEW THE STAPLE LINE TO ENSURE ADEQUATE REINFORCEMENT/HEMOSTASIS. A PHOTOGRAPH WAS RECEIVED FOR REVIEW. BASED ON THE PHOTOGRAPHIC EVIDENCE, IT IS BELIEVED THE INNER TWO ROWS OF STAPLES DID NOT PROPERLY DEPLOY AND SUPPORTS THE EVENT DESCRIPTION ¿TWO STAPLE PUSHER BARS APPEARED NOT TO HAVE DEPLOYED. THIS OCCURRED ON PATIENT SIDE, SECOND STAPLE ON MEDIAL ROW (INSIDE ROW) AND ON THE SECOND STAPLE ON MIDDLE ROW SEAT DEEP WITHIN THE CARTRIDGE¿. HOWEVER THE PHOTOGRAPHS DO NOT PROVIDE EVIDENCE RELATIVE TO WHAT MAY HAVE CAUSED THE INCOMPLETE STAPLE DEPLOYMENT. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THE BATCHES INCLUDED IN THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY PROCEDURE, UPON THE FIRST FIRING, THE BLACK RELOAD WITH SEAM GUARD WAS USED ON THE ANVIL ONLY. THE STAPLER APPEARED TO PERFORM AS PER EXPECTATION, HOWEVER UPON CLOSER INSPECTION OF THE STAPLE LINE, TWO STAPLE PUSHER BARS APPEARED NOT TO HAVE DEPLOYED. THIS OCCURRED ON PATIENT SIDE, SECOND STAPLE ON MEDIAL ROW (INSIDE ROW) AND ON THE SECOND STAPLE ON MIDDLE ROW SEAT DEEP WITHIN THE CARTRIDGE (PHOTO AVAILABLE). UPON CLOSER INSPECTION OF THE STAPLE LINE, THE STAPLES APPEARED UNABLE TO BE SEEN. THE SURGEON CONSEQUENTLY HAD TO OVER SEW THE STAPLE LINE TO ENSURE ADEQUATE REINFORCEMENT/HEMOSTASIS. THE PROCEDURE WAS DELAYED FOR ABOUT THIRTY MINUTES. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256001 PWRD ECH FLEX 60MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4C38X

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD-ECR60T