BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPROCESSED ETHICON TROCAR

    MDR report key: 1009819 · Received February 7, 2008

    Report

    Report Number
    1009819
    Event Type
    Malfunction
    Date Received
    February 7, 2008
    Date of Event
    January 21, 2008
    Report Date
    January 30, 2008
    Manufacturer
    ASCENT HEALTHCARE SOLUTIONS
    Product Code
    NMK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DC, US

    Narratives

    Description of Event or Problem · 1

    A TOTAL OF 5 REPROCESSED TROCARS BROKE APART DURING USE. ONE WAS FROM LOT NUMBER 149680, THREE WERE FROM LOT NUMBER 149764, AND ONE WAS FROM AN UNKNOWN LOT NUMBER. THE FIVE BROKEN TROCARS WERE SENT TO THE MANUFACTURER (REPROCESSOR) FOR ANALYSIS. THE REPROCESSOR'S ANALYSIS INDICATED THAT, BASED ON THEIR FINDINGS, A CHANGE WOULD BE MADE IN THE DISASSEMBLY PROCEDURE INVOLVED IN REPROCESSING THIS TROCAR. ACCORDING TO THE REPROCESSOR, "THIS MODIFICATION WILL ASSIST IN MITIGATING FUTURE OCCURRENCES OF THIS NATURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPROCESSED ETHICON TROCAR TROCAR NMK ASCENT HEALTHCARE SOLUTIONS XCEL BLUNT TIP 149680
    2 REPROCESSED ETHICON TROCAR TROCAR NMK ASCENT HEALTHCARE SOLUTIONS H12LP 149764
    3 REPROCESSED ETHICON TROCAR TROCAR NMK ASCENT HEALTHCARE SOLUTIONS XCEL BLUNT TIP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *