BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS FLEX

    MDR report key: 136454 · Received November 26, 1997

    Report

    Report Number
    1527736-1997-03146
    Event Type
    Malfunction
    Date Received
    November 26, 1997
    Date of Event
    September 8, 1997
    Report Date
    October 28, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    KOG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS USED DURING A V.A.T.S. PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT THE STAPLES WERE MALFORMED. A TR24 CARTRIDGE IS BEING RETURNED WITH THE DEVICE (LOT# K46N21/BATCH#K00261). THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS FLEX LINEAR CUTTER KOG ETHICON ENDO-SURGERY, INC. NA K47620

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other