BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 4213390 · Received October 30, 2014

    Report

    Report Number
    3005075853-2014-07481
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 13, 2014
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS RESULTS THAT ONE PLE60A DEVICE WAS RETURNED WITH NO VISUAL NON-CONFORMANCES AND WITHOUT A CARTRIDGE RELOAD PRESENT. IN ADDITION A CARTRIDGE PAN WAS FOUND LODGED INSIDE THE CHANNEL. THE PAN WAS REMOVED FROM THE CHANNEL AND THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD. THE DEVICE FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. WHILE NO CONCLUSION COULD BE REACHED AS TO HOW THE PAN BECAME DISLODGED FROM THE RELOAD, IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS. NO DAMAGE ON CARTRIDGE WAS FOUND DURING VISUAL INSPECTION. THE REPORTED EVENTS COULD NOT BE CONFIRMED AS NO INCOMPLETE STAPLE LINE O MALFORMED STAPLES WERE NOTED DURING FUNCTIONAL TESTING. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, ON THE FIFTH FIRING, THE DEVICE WAS FIRED AND IT APPEARED THE RELOAD WAS HUNG UP ON SOMETHING. THE RELOAD WAS POPPED OUT OF THE DEVICE TO LOOK AT THE BOTTOM. THE METAL TRAY ON THE BOTTOM OF THE CARTRIDGE CAME OFF AND REMAINED IN THE JAWS OF THE STAPLER. IT WAS NOTED THE INNER TWO ROWS HAD THE SLED VEERING INTO THE LANES. THE TWO MEDIAL ROWS DID NOT DEPLOY THE STAPLES PROPERLY. SOME STAPLES WERE DELIVERED IN THE TISSUE AND NOT FORMED PROPERLY AND SOME STAPLES WERE NOT DELIVERED INTO THE TISSUE. THERE WAS NO ISSUE WITH THE CUT LINE. THE PROCEDURE WAS COMPLETED BY OVERSEWING. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695709 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 DEVICE - PLE60A