BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH DILATING TIP TROCAR

    MDR report key: 154048 · Received March 4, 1998

    Report

    Report Number
    1527736-1998-00630
    Event Type
    Malfunction
    Date Received
    March 4, 1998
    Date of Event
    February 3, 1998
    Report Date
    February 5, 1998
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TRACKING #.49872. EES #.981329/J. ENDOPATH DILATING TIP TROCAR: BASED ON INFORMATION REC'D AND FUNCTIONALITY TESTING, INSTRUMENTS A & B FAILED TO ARM DUE TO A SKEWED END CAP WELD. INSTRUMENTS C & D FUNCTIONED AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE 355SD WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE AFFILIATES, BUTTON TO ACTIVATE THE SAFETY SHIELD DOES NOT LOCK (SOMETIMES IT DOES, BUT MOSTLY NOT) AND SO THE DEVICE COULD NOT BE USED IN AN APPROPRIATE WAY. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH DILATING TIP TROCAR ENDOPATH DILATING TIP GCJ ETHICON ENDO-SURGERY, INC. NA K4832Z

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other