BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERI MED, INC ETHICON TROCAR BLUNT TIP ENDOPATH XCEL

    MDR report key: 1510249 · Received October 14, 2009

    Report

    Report Number
    MW5013017
    Event Type
    Injury
    Date Received
    October 14, 2009
    Date of Event
    September 29, 2009
    Report Date
    October 14, 2009
    Manufacturer
    STERILE MED REPROCESSOR
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT IN SURGERY FOR LAP CHOLE. DURING PROCEDURE, "ETHICON TROCAR BLUNT TIP ENDOPATH XCEL WITH STABILITY CONE" BROKE DURING NORMAL USAGE. ALL PARTS RETRIEVED FROM PT AND NEW INSTRUMENT OPENED. BROKEN INSTRUMENT RETURNED TO MATERIALS MANAGER'S OFFICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERI MED, INC ETHICON TROCAR BLUNT TIP ENDOPATH XCEL HUSSAN GCJ STERILE MED REPROCESSOR ETHH12LP 658022

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Disability