BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 3107275 · Received May 10, 2013

    Report

    Report Number
    3005075853-2013-02234
    Event Type
    Malfunction
    Date Received
    May 10, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 4, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS. SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE DEVICE WAS NOT RECEIVED FOR ANALYSIS; THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS. NO FURTHER INVESTIGATION CAN BE PERFORMED AT THIS TIME. THIS COMPLAINT IS BEING CLOSED TO TRENDING. ADDITIONAL INFORMATION REQUESTED AND RECEIVED: WHAT DEVICE WAS USED IN THE PROCEDURE? ECR60G AND PLE 60 A. ON WHICH FIRING DID THE EVENT OCCUR? FIRST FIRING. PLEASE EXPLAIN WHAT IS MEANT BY, THE CARTRIDGE MISFIRED. CARTAGE DID NOT STAPLE. IF BUTTRESSING MATERIAL WAS UTILIZED, WHICH PRODUCT WAS USED? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO - IT WAS FIRST FIRING. HOW WAS THE CASE COMPLETED? SUTURED THE STAPLE LINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY PROCEDURE THE CARTRIDGE MISFIRED. NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205966 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4CF4X

    Patients

    Seq Age Sex Outcome Treatment
    1