BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON ENDOPATH 512 X AND 512S TROCARS

    MDR report key: 26445 · Received January 18, 1995

    Report

    Report Number
    26445
    Event Type
    Injury
    Date Received
    January 18, 1995
    Date of Event
    September 29, 1994
    Report Date
    October 5, 1994
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    FBQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING ELECTIVE LAPAROSCOPIC PROCEDURE. LACERATION TO SMALL BOWEL AND RIGHT ILIAC ARTERY & VEIN RESULTED FOLLOWING PUNCTURE BY TROCAR. PATIENT INCURRED LARGE VOLOME OF BLOOD LOSS REQUIRING MULTIPLE TRANSFUSIONS; REQUIRED EMERGENCY LAPAROTOMY AND REPAIR AND GRAFTING OF RT. ILIAC ARTERY/VEIN, REPAIR OF SMALL BOWEL TEAR; CYSTOSCOPY; INSERTION OF R URETERAL STENT.NOTE: AS OF THIS DATE, THERE IS NO DETERMINATION OF ACTUAL CAUSE, I.E., USER ERROR VS EQUIPMENT FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDOPATH 512 X AND 512S TROCARS DISPOSABLE 10/12 TROCARS FBQ ETHICON ENDO-SURGERY 512X 512S GB5008 GG4747

    Patients

    Seq Age Sex Outcome Treatment
    1 25 * Hospitalization| L| R| S (9) AVAILABLE ONLY UNDER SPECIAL CONDITIONS.