BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH DILATING TIP TROCAR

    MDR report key: 164782 · Received April 24, 1998

    Report

    Report Number
    1527736-1998-01276
    Event Type
    Malfunction
    Date Received
    April 24, 1998
    Date of Event
    March 26, 1998
    Report Date
    March 31, 1998
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    TRACKING #.50960. EES #.982287/J. D5,6; H4: INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 355SD WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT THE SURGEON COULD NOT INSERT THE DEVICE INTO THE ABDOMINAL WALL DUE TO THE KNIFE BLADE WAS NOT EXPOSED. A NEW TROCAR WAS USED 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 TROCAR GCJ ETHICON ENDO-SURGERY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other