BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK-WILSON MEDICAL PERCUTANEOUS ENDOSCOPIC

    MDR report key: 1059492 · Received June 9, 2008

    Report

    Report Number
    MW5007254
    Event Type
    Malfunction
    Date Received
    June 9, 2008
    Date of Event
    May 30, 2008
    Report Date
    June 9, 2008
    Manufacturer
    COOK-WILSON
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS HAVING PEG TUBE PLACEMENT. WHEN SURGEON WAS PULLING GUIDE WIRE WHICH WAS HELD IN PLACE BY GRASPER VIA ENDOSCOPE, THE WIRE PULLED THROUGH THE SKIN. WIRE IS DESIGNED NOT TO BE PULLED THROUGH TROCAR, BUT CAME THROUGH. NO INJURY TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK-WILSON MEDICAL PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE KNT COOK-WILSON PEG-24-PULL-S

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR