BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH DILATING TIP TROCAR

    MDR report key: 299142 · Received October 3, 2000

    Report

    Report Number
    1527736-2000-04734
    Event Type
    Malfunction
    Date Received
    October 3, 2000
    Date of Event
    August 25, 2000
    Report Date
    September 5, 2000
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    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 THAT (1) 355LD WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE REP THAT THEY CLAIM TROCAR BLADE WOULD NOT RETRACT. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. THERE WAS NO CONSEQUENCE TO PT. IN 2000 CASE WAS COMPLETED SUCCESSFULLY WITH ANOTHER TROCAR-DSH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH DILATING TIP TROCAR TROCARS GCJ ETHICON ENDO-SURGERY, INC. NA N4J37R

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other