BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60 ENDOPATH STAPLER

    MDR report key: 1003620 · Received February 15, 2008

    Report

    Report Number
    1527736-2008-00935
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Report Date
    April 22, 2007
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE ANALYSIS RESULTS SHOWED THAT ONE DEVICE WAS RECEIVED WITH THE HANDLES OPEN, WITH THE INDICATOR DISC BROKEN AND WITH A VOID OF STAPLES CARTRIDGE LOADED ON THE DEVICE. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND NO ANOMALIES WERE FOUND. WHILE NO CONCLUSION COULD BE REACHED AS TO HOW THE DEVICE BECAME DAMAGED, IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    THE DEVICE WAS RECEIVED WITH NO FURTHER INFORMATION IS AVAILABLE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 60 ENDOPATH STAPLER GDW ETHICON ENDO-SURGERY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1