BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER RELOAD

    MDR report key: 4870015 · Received June 25, 2015

    Report

    Report Number
    3005075853-2015-03888
    Event Type
    Malfunction
    Date Received
    June 25, 2015
    Date of Event
    June 5, 2015
    Report Date
    June 5, 2015
    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
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: THE STAPLE LINE THAT DID NOT FORM; WHAT WAS THE APPEARANCE OF THE DEPLOYED STAPLES? - IT WAS AN ORIGINAL FORM, IT DID NOT FORM THE B-SHAPE. WERE THERE STAPLES MISSING FROM THE STAPLE LINE?- YES. SOME OF THEM WERE IN THE STAPLE LINE BUT OTHERS WERE NOT IN THE STAPLE LINE. DID THE DEVICE CUT?- YES. IF THE DEVICE CUT WAS THE CUT LINE COMPLETE?- THE CUT LINE WAS COMPLETE BUT NOT THE STAPLE LINE.

    Additional Manufacturer Narrative · 1

    (B)(4). CARTRIDGE, DRIVERS. THE ANALYSIS FOUND THAT ONE ECR60T CARTRIDGE RELOAD WAS RECEIVED FOR ANALYSIS AND CARTRIDGE BODY WAS NOTED TO BE DAMAGED. THE RELOAD WAS RECEIVED FULLY FIRED. UPON FURTHER EVALUATION THE CARTRIDGE DECK AND SOME DRIVERS WERE NOTED TO BE DAMAGED. THE DAMAGE TO THE CARTRIDGE IS CONSISTENT WITH THE DEVICE BEING CLAMPED OVER A HARD OBJECT. WHEN THIS HAPPENS THE CARTRIDGE GETS INDENTED THEREFORE THERE IS NOT ENOUGH SPACE FOR THE SLED PUSHING THE DRIVER TO CONTINUE ITS RUN, THIS IS THE REASON WHY THE SLED SOMETIMES GETS DAMAGED. NO FURTHER FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. 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 A VIDEO ASSISTED THORACOSCOPIC LOBECTOMY PROCEDURE, WHEN THE SURGEON TRIED TO TRANSECT THE BRONCHUS WITH THE DEVICE AND A BLACK RELOAD, THE STAPLE LINE DID NOT FORM WELL. THE SURGEON HAD TO SUTURE AT EVERY SITE OF TRANSECTION TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411392 ECHELON LINEAR CUTTER RELOAD STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 DEVICE - PSE60A