BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS-FLEX - ENDOSCOPIC ARTICULATING LINEAR CUTTER (VASCULAR/THIN) - 35 MM

    MDR report key: 1823764 · Received December 13, 2007

    Report

    Report Number
    1527736-2007-08474
    Event Type
    Malfunction
    Date Received
    December 13, 2007
    Report Date
    January 4, 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

    (B)(4). EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE INSTRUMENT WAS RETURNED WITH THE FIRING TRIGGER DAMAGED AND WITHOUT A CARTRIDGE. THE INSTRUMENT WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE FIRING TRIGGER TEETH WERE FOUND TO BE BROKEN. NO FUNCTIONAL TEST WAS PERFORMED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    THE DEVICE RECEIVED WAS RECEIVED WITH NO DETAILS. THERE WAS NO REPORTED PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS-FLEX - ENDOSCOPIC ARTICULATING LINEAR CUTTER (VASCULAR/THIN) - 35 MM GDW ETHICON ENDO SURGERY, INC (CINCINNATI) NA Y59YL

    Patients

    Seq Age Sex Outcome Treatment
    1