BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH DISPOSABLE SURGICAL TROCAR

    MDR report key: 42827 · Received October 15, 1996

    Report

    Report Number
    9680598-1996-00120
    Event Type
    Malfunction
    Date Received
    October 15, 1996
    Date of Event
    August 6, 1996
    Report Date
    October 10, 1996
    Manufacturer
    ETHICON ENDO SURGICAL, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS USED DURING A DIAGNOSTIC LAP. IT WAS REPORTED THE 512 S HAD A NOTE WRITTEN ON THE BLISTER STATING "SAFETY SWITCH, OR RED BUTTON, KEEP RELEASING WITHOUT DOCTOR BEING IN THE ABDOMINAL CAVITY". REP COULD OBTAIN NO FURTHER INFO REGARDING THE EVENT. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH DISPOSABLE SURGICAL TROCAR DISPOSABLE SURGICAL TROCAR GCJ ETHICON ENDO SURGICAL, INC. NA J4392C

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other