BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS

    MDR report key: 112815 · Received August 12, 1997

    Report

    Report Number
    1527736-1997-01942
    Event Type
    Malfunction
    Date Received
    August 12, 1997
    Report Date
    July 14, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    KOG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS UNUSED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED THE JAWS OF THE TSW35 WERE LOCKED. THERE WAS NO CONSEQUENCE TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other