BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH DILATING TIP TROCAR

    MDR report key: 167200 · Received May 8, 1998

    Report

    Report Number
    1527736-1998-01399
    Event Type
    Malfunction
    Date Received
    May 8, 1998
    Date of Event
    April 8, 1998
    Report Date
    April 8, 1998
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE REP THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED INSIDE THE "O" RING OF THE TROCAR FELL INTO PTS ABDOMEN. THE SURGEON NOTICED THE TROCAR WAS LOOKING RIGHT BEFORE THE RING CAME OFF. THE TROCAR WAS FROM A LAPAROSCOPIC CHOLECYSTECTOMY KIT LOT# (I48W3D), BATCH# (2002-12). IT WAS REMOVED AND A NEW TROCAR WAS OPENED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other