BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1491830 · Received September 21, 2009

    Report

    Report Number
    3005075853-2009-05705
    Event Type
    Malfunction
    Date Received
    September 21, 2009
    Date of Event
    August 13, 2009
    Report Date
    August 27, 2009
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    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: 9/21/2009. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    .

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1