BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENT REPROCESSED TROCAR B5LT

    MDR report key: 1623587 · Received February 26, 2010

    Report

    Report Number
    MW5014996
    Event Type
    Malfunction
    Date Received
    February 26, 2010
    Date of Event
    January 29, 2010
    Report Date
    February 26, 2010
    Manufacturer
    ASCENT HEALTHCARE SOLUTIONS
    Product Code
    NMK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SURGEON OPENED REPROCESSED STERILE TROCAR WHEN HE SAW A RED SUBSTANCE ON THE OUTSIDE OF THE TROCAR. SURGEON GAVE THE CONTAMINATED TROCAR TO ASSISTANT AND IT WAS RETURNED TO ASCENT, THE REPROCESSING COMPANY FOR ANALYSIS. LAB ANALYSIS CONDUCTED BY ASCENT DETERMINED THAT THE SUBSTANCE WAS HEMOGLOBIN. WE DO NOT FEEL THAT THEIR LACK OF URGENCY OR ATTENTION TO THIS MATTER WAS APPROPRIATE FOR THE SERIOUSNESS OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENT REPROCESSED TROCAR B5LT TROCAR NMK ASCENT HEALTHCARE SOLUTIONS B5LT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other