BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENDOPATH 10MM TROCAR

    MDR report key: 21122 · Received January 14, 1994

    Report

    Report Number
    21122
    Event Type
    Other
    Date Received
    January 14, 1994
    Date of Event
    September 9, 1993
    Report Date
    September 20, 1993
    Manufacturer
    ETHICON
    Product Code
    DRC
    Report Source
    User Facility report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT IN FOR LAPAROSCOPIC CHOLECYSTECTOMY. AFTER INSERTION OF THE 10MM TROCAR AND SLEEVE, THE PLASTIC LEAFLET TIP OF TROCAR WITH OBSERVED TO HAVE BROKEN OFF. SURGEON ATTEMPTED TO REMOVE PIECE, BUT WAS UNABLE TO BECAUSE IT CONTINUED TO FURTHER ADVANCE INTO THE FATTY SUBCUTANEOUS TISSUE. SURGEON STATED HE WOULD INFORM PATIENT OF INCIDENT AT FOLLOW-UP OFFICE VISIT. NO OBVIOUS INJURY AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH 10MM TROCAR TROCAR DRC ETHICON TROCAR PRODUCT #T5111 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 38 * Other