BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON ENDO-SURGERY LLC

    MDR report key: 1893461 · Received November 5, 2010

    Report

    Report Number
    1893461
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 1, 2010
    Manufacturer
    ETHICON
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A 5MM TROCAR BROKE INTO TWO PIECES WHILE BEING USED BY DR. (B)(6) DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR. BOTH PIECES RETRIEVED WITHOUT DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO-SURGERY LLC 5MM BLADELESS ENDOPATH XCEL TROCAR GCJ ETHICON B5LT

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other