BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER RELOAD

    MDR report key: 4131306 · Received October 1, 2014

    Report

    Report Number
    3005075853-2014-06769
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    September 16, 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
    JA
    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 Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ECR60D PACKAGE WAS VISUALLY INSPECTED FOR SEAL INTEGRITY. AT RECEIPT OF THE SAMPLE, THE SEAL OF THE PACKAGE WAS PARTIALLY PULLED APART. WHILE THE SEAL TAB AREA WAS PARTIALLY SEPARATED, THE SEAL WAS STILL PRESENT AND THE DEVICE WAS STILL CONSIDERED TO STERILE. THE PACKAGE WAS OPENED AND AN ULTRAVIOLET (BLACK) LIGHT WAS USED TO VISUALIZE THE SEAL TRANSFER ON THE PACKAGE. IT WAS VERIFIED THAT THE SEAL TRANSFER WAS PRESENT AND THAT AT THE END OF THE PACKAGING PROCESS THAT THE SEAL WAS INTACT. AT AN UNKNOWN TIME, THE SEAL WAS PARTIALLY PULLED BACK. THE COMPLAINT IS NOT CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE AN UNKNOWN PROCEDURE, THE SEAL OF THE SEALED PACKAGE WAS NEARLY UNSTUCK. THE PACKAGE WAS NOT OPENED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611417 ECHELON LINEAR CUTTER RELOAD STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4E952

    Patients

    Seq Age Sex Outcome Treatment
    1