BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON

    MDR report key: 2091685 · Received May 17, 2011

    Report

    Report Number
    3005075853-2011-02005
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Report Date
    April 21, 2011
    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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS SHOWED THAT ONE ECR60W CARTRIDGE RELOAD WAS RECEIVED FULLY FIRED. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE RELOAD. EVENT COULD NOT BE CONFIRMED AS NO INSTRUMENT WAS RECEIVED FOR ANALYSIS. FIELD QUALITY ENGINEER REVIEWED THE 4 PHOTOGRAPHS RETURNED. BASED ON THE CLARITY AND SUBJECT MATTER OF SOME OF THE PHOTOGRAPHS, NO POTENTIAL CAUSE COULD BE DETERMINED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP GASTRIC BYPASS PROCEDURE, THE TISSUE BLOCKED ITSELF IN THE MAGAZINE, A TEAR OF 3MM DEVELOPED IN THE JEJUNUM, SUTURED BY HAND. NO FURTHER INFORMATION IS AVAILABLE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK G4UH5M

    Patients

    Seq Age Sex Outcome Treatment
    1