BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 3802265 · Received May 9, 2014

    Report

    Report Number
    3005075853-2014-03145
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE. 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: WHAT IS THE CURRENT STATUS OF THE PATIENT? PATIENT IS ALIVE AND HAS NO COMPLAINTS. DID THE POST-OPERATIVE CARE CHANGED BASED ON THE EVENT? NO INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION WITH NO CARTRIDGE RELOAD PRESENT. AFTER FURTHER ANALYSIS, THE CLAMPING MECHANISM WAS NOTED TO BE DAMAGED; THEREFORE NO FUNCTIONAL TEST COULD BE PERFORMED. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS; THE RELEASE BUTTON AND RELEASE BUTTON POST WAS NOTED TO BE BROKEN, THIS DAMAGE IS CONSISTENT WITH APPLYING A LARGE PRYING FORCE ON THE CLOSURE TRIGGER HANDLE IN THE OPENING DIRECTION. AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE NURSE PASSED STERILE DEVICE TO SURGEON. THE DOCTOR LOADED THE YELLOW CARTRIDGE. DEVICE WAS INTRODUCED INTO THE ABDOMINAL CAVITY THROUGH A TROCAR. AFTER THREE STEPS FIRING ON GREATER CURVATURE OF THE STOMACH THE DEVICE DID NOT OPEN. ALL POSSIBLE STEPS TO OPEN THE DEVICE WERE MADE ACCORDING TO INSTRUCTIONS. THE DEVICE DID NOT OPEN AFTER FIRING. THE DEVICE WAS ABLE TO BE REMOVED ONLY BY USING THE DISSECTOR, A LITTLE BIT CUTTING THE TISSUE AROUND THE SUTURE. THEN HAD TO COVER LINE MECHANICAL SUTURE SEAM WITH THREAD VELOK. DELAY OF THIRTY MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280913 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1