BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER,45MM STAPLE LINE-2.5MM

    MDR report key: 1003630 · Received February 15, 2008

    Report

    Report Number
    1527736-2008-00924
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Report Date
    June 29, 2005
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 02/15/2008. BATCH NUMBER. TWO DEVICES (A-B) WERE RETURNED FOR ANALYSIS. BOTH DEVICES WERE RETURNED WITH THE FIRING MECHANISM DAMAGED AND WITH NO CARTRIDGE PRESENT. THE DEVICES WERE DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE FIRING TRIGGER TEETH WERE FOUND BROKEN, NO FUNCTIONAL TEST WAS PERFORMED. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATION. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS. DEVICE B ADDITIONAL INFORMATION: D4: BATCH #Y5F370.

    Description of Event or Problem · 1

    THE DEVICE WAS RECEIVED WITH NO FURTHER INFORMATION. THERE WAS NO REPORTED PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER,45MM STAPLE LINE-2.5MM GDW ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1