BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON XCEL BLUNT TIP TROCAR 12 X 100MM

    MDR report key: 1564895 · Received December 18, 2009

    Report

    Report Number
    MW5014092
    Event Type
    Malfunction
    Date Received
    December 18, 2009
    Date of Event
    December 18, 2009
    Report Date
    December 18, 2009
    Manufacturer
    ASCENT HEALTHCARE SOLUTIONS
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ASCENT REPROCESSED ETHICON XCEL BLUNT TIP TROCAR 12 X 100MM H12LP. I AM HAVING A 75% BREAKAGE RATE WITH THE CLIP ANCHOR AND THE SUTURE TIE DOWN PEGS. THEY ARE BREAKING, AS SCRUB TECHS ARE ASSEMBLING THEM AND AS THE SURGEON IS ATTEMPTING TO TIE DOWN HIS SUTURE. THERE IS NO WAY TO SEE IF PLASTIC SHAVINGS ARE COMING OFF OR ENTERING THE SURGICAL SIGHT. LOT # 840848; THIS TROCAR IS USED IN ALL LAPAROSCOPIC CASES. DATES OF USE: 2009. DIAGNOSIS OR REASON FOR USE: LAPAROSCOPIC HERNIA; LAPAROSCOPIC APPENDECTOMY/LAPAROSCOPIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON XCEL BLUNT TIP TROCAR 12 X 100MM HASAN TROCAR GCJ ASCENT HEALTHCARE SOLUTIONS 840848
    2 ETHICON XCEL BLUNT TIP TROCAR 12 X 100MM HASAN TROCAR GCJ ASCENT HEALTHCARE SOLUTIONS 796663

    Patients

    Seq Age Sex Outcome Treatment
    1 Other