BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP CHOLE CDS - LF

    MDR report key: 1002827 · Received February 21, 2008

    Report

    Report Number
    MW5005637
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    February 19, 2008
    Report Date
    February 21, 2008
    Manufacturer
    MEDLINE INDUSTRIES
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WITHIN THE MEDLINE LAP CHOLE CDS IS A UNIVERSAL TROCAR CAP MANUFACTURED BY CONMED. DURING SURGERY, THE PHYSICIANS OBSERVED A PLASTIC RING/GASKET (COMPONENT OF THE CONMED CAP) IN THE PT (AREA OF THE PROCEDURE). THE PIECE WAS REMOVED AND SAY ASIDE WITH THE CAP. NO HARM TO PT, * LOT # MEDLINE LAP CHOLE. THE LOT # OF THE DEVICE IN QUESTIONS IS 0704171 MEDLINE AWARE AND CHECKING ALL STOCK FOR THE CONMED, LOT# AND INFORMANT CONMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP CHOLE CDS - LF UNIVERSAL CAP BY CONMED W/THIN LAP CHOLE GCJ MEDLINE INDUSTRIES CD5930072F 07HD3903*

    Patients

    Seq Age Sex Outcome Treatment
    1 YR