BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELOADABLE LINEAR CUTTER

    MDR report key: 3903036 · Received June 30, 2014

    Report

    Report Number
    3005075853-2014-04501
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPY EXAM AND LAPAROSCOPIC APPENDECTOMY, THE SURGEON FIRED THE DEVICE FOR THE FIRST FIRING AND WHEN THE STAPLE LINE WAS OBSERVED THE STAPLES WERE OPEN ON THE ENDS AND MALFORMED. THE SURGEON HEARD NO NOISE OR HAD NO DIFFICULTY FIRING THE DEVICE. HE REMOVED IT FROM THE TISSUE WITH NO ISSUES. THEY USED A SECOND LIKE DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380759 RELOADABLE LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1