BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH DISPOSABLE SURGICAL TROCAR

    MDR report key: 150354 · Received February 19, 1998

    Report

    Report Number
    1527736-1998-00449
    Event Type
    Malfunction
    Date Received
    February 19, 1998
    Date of Event
    January 23, 1998
    Report Date
    January 23, 1998
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 512X CANNULA BROKE DURING INSERTION. 9/7/95-REP REPORTED THAT THE CANNULA BROKE INTO FOUR OR FIVE PIECES AT THE DISTAL END. THE NURSES FELT THAT ALL OF THE PIECES WERE RETRIEVED, THE PIECES ARE BEING RETURNED WITH THE INSTRUMENT. 9/11/95 1555 SURGEON RETURNED CALL. SURGEON STATED THE PT WAS VERY OBESE AND HE THOUGHT THERE WAS TOO MUCH PRESSURE PLACED UPON THE TROCAR. HE WENT ON TO SAY THIS WAS A VERY UNUSUAL CASE AND HE STRUGGLED THROUGHOUT THE ENTIRE PROCEDURE. THE TROCAR BROKE MID-WAY THROUGH THE PROCEDURE AS THE SURGEON WAS TRYING TO DISSECT THE GALLBLADDER FROM THE LIVER BED. AT THIS TIME HE STATED HE WAS PUTTING A LOT OF PRESSURE ON THE TROCAR TRYING TO GET THE DISSECTOR TO REACH THE LIVER BED. THE SURGEON STATED HE DID NOT FEEL IT WAS A PROBLEM WITH THE TROCAR, BUT FELT IT WAS THE CIRCUMSTANCES OF THIS CASE. HE DID FEEL ALL PIECES OF THE TROCAR WERE RETRIEVED. 1/23/98 REC'D PHONE CALL FROM THE SURGEON WHO STATED PT IS NOW LITIGATING. PT HAD C-SECTION DELIVERY AND A "SLIVER" OF THE TROCAR WAS FOUND DURING THIS PROCEDURE. ALLEGEDLY, THE PT HAD BEEN EXPERIENCING PAIN. HE REQUESTED INFO RE: MATERIALS OF THE TROCAR AND FACILITY ASKED HIM TO PUT REQUEST IN WRITING. 2/13/98 RESPONSE AND INFO SENT TO THE SURGEON.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other