BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTH NET PLATINUM FOOD BOLUS RETRIEVER

    MDR report key: 2802753 · Received September 17, 2012

    Report

    Report Number
    2802753
    Event Type
    Malfunction
    Date Received
    September 17, 2012
    Date of Event
    June 14, 2012
    Report Date
    September 17, 2012
    Manufacturer
    US ENDOSCOPY
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE, WHILE THE SURGEON WAS ATTEMPTING TO TIGHTEN THE ROTH NET AND PULLING BACK ON THE HANDLE, A PIECE OF PLASTIC ON THE HANDLE CAME APART PREVENTING THE NET FROM CLOSING AROUND A TISSUE SAMPLE. STAFF REMOVED THE PIECE OF EQUIPMENT FROM THE SCOPE. THEY WERE STILL ABLE TO COLLECT THE TISSUE THAT THE INSTRUMENT WAS BEING USED FOR. THERE WERE NO REMNANTS LEFT IN THE PATIENT. A NEW INSTRUMENT WAS USED TO RETRIEVE THE TISSUE SAMPLE. IT IS UNKNOWN IF THE NEW INSTRUMENT WAS OF THE SAME OR A DIFFERENT LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTH NET PLATINUM FOOD BOLUS RETRIEVER FOOD BOLUS RETRIEVER KOG US ENDOSCOPY * 67468

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR