BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS*45 ENDO

    MDR report key: 1962087 · Received January 17, 2011

    Report

    Report Number
    3005075853-2011-00213
    Event Type
    Malfunction
    Date Received
    January 17, 2011
    Date of Event
    December 24, 2010
    Report Date
    December 26, 2010
    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
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT TWO TR45G RELOADS WERE RECEIVED IN GOOD VISUAL CONDITION. RELOAD (A) WAS RECEIVED FULLY FIRED; RELOAD (B) WAS RECEIVED FULLY LOADED WITH STAPLES. THE RETURNED RELOAD (B) WAS TESTED FOR FUNCTIONALITY WITH A TEST INSTRUMENT AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE DEVICE FIRED AND CUT WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE, THE CUT LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. EVENT COULD NOT BE CONFIRMED AS NO INSTRUMENT WAS RECEIVED FOR ANALYSIS. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE STAPLES DID NOT CHANGE COMPLETELY TO THE "B" SHAPE. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS*45 ENDO STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1