BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIL OPTICAL ACCESS SYSTEM

    MDR report key: 1700438 · Received May 21, 2010

    Report

    Report Number
    MW5016084
    Event Type
    Malfunction
    Date Received
    May 21, 2010
    Date of Event
    May 17, 2010
    Report Date
    May 21, 2010
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD A LAPAROSCOPIC LEFT ADRENALECTOMY. A 12 MM APPLIED TROCAR WAS FOUND WITH A BROKEN PIECE AT THE LIP. THIS WAS NOTICED AT THE END OF THE PROCEDURE. THERE WAS AN ASSOCIATED LINEAR CRACK AS WELL. THE PHYSICIAN AND STAFF WERE UNABLE TO VISUALIZE THE PIECE OF THE TROCAR WITHIN THE PT. NO X-RAYS WERE DONE AS THEY WOULD NOT BE HELPFUL SINCE THE MATERIAL IS NOT RADIOPAQUE. IT IS STILL UNCLEAR IF THE TROCAR IS IN THE ABDOMEN. THE DECISION WAS MADE NOT TO PROCEED WITH SURGICAL REMOVAL DUE TO THE PT'S BODY MASS, BECAUSE IT IS UNCLEAR THAT THE TROCAR IS IN THE ABDOMEN. THE PT WAS NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIL OPTICAL ACCESS SYSTEM OPTICAL ACCESS SYSTEM GCJ APPLIED MEDICAL C0R30

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other