BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER RELOAD

    MDR report key: 3973843 · Received August 1, 2014

    Report

    Report Number
    3005075853-2014-05439
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 23, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS RESULTS SHOWED THAT ONE ECR60B CARTRIDGE RELOAD WAS RETURNED INSIDE ITS STERILE PACKAGE AND WITH 4 DRIVERS OUT OF POSITION MAKING THE RELOAD NON-FUNCTIONAL. IN ADDITION, THE CARTRIDGE PAN WAS NOTED TO BE DISLODGED AT LEFT PROXIMAL SIDE WHICH LEADED THE DRIVERS TO LOSE THEIR INTENDED POSITION. IN ADDITION, IT SHOULD BE NOTED THAT 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 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 PRIOR TO AN UNKNOWN PROCEDURE, WHEN PULLING PRODUCT FOR A FUTURE CASE, IT WAS NOTED SEVERAL OF THE ORANGE DRIVERS WERE DISLODGED FROM THE RELOAD AND "FREE" IN THE UNOPENED PACKAGE. RELOAD WAS NEVER OPENED. CASE COMPLETED WITH ANOTHER RELOAD OF THE SAME PRODUCT CODE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451227 ECHELON LINEAR CUTTER RELOAD STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4ET8P

    Patients

    Seq Age Sex Outcome Treatment
    1