BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTH NET PLATINUM

    MDR report key: 2854327 · Received November 28, 2012

    Report

    Report Number
    1528319-2012-00027
    Event Type
    Malfunction
    Date Received
    November 28, 2012
    Date of Event
    June 14, 2012
    Report Date
    November 28, 2012
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP, INC.
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MEDWATCH REPORT INDICATES THAT THE CUSTOMER USED ANOTHER DEVICE TO SUCCESSFULLY COLLECT THE TISSUE AND COMPLETE THE PROCEDURE. THERE WAS NO REPORT THAT ANY PORTION OF THE DEVICE FELL INTO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THERE WAS NO INJURY TO EITHER PATIENT OR USER. REVIEW OF THE LOT HISTORY RECORD INDICATES NO PROBLEMS IN THE MANUFACTURING OF THIS DEVICE.

    Description of Event or Problem · 1

    THE ROTHNET DEVICE IS USED IN THE ENDOSCOPIC RETRIEVAL OF FOREIGN BODY, FOOD BOLUS AND EXCISED TISSUE SUCH AS POLYPS. ON (B)(6) 2012 US ENDOSCOPY RECEIVED A MEDWATCH REPORT, (B)(4) REGARDING THE FOLLOWING: "DURING A PROCEDURE, WHILE THE SURGEON WAS ATTEMPTING TO TIGHTEN THE DEVICE 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 ENDOSCOPE. 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 OF THE SAME OR A DIFFERENT LOT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTH NET PLATINUM ROTH NET KOG UNITED STATES ENDOSCOPY GROUP, INC. 711155 67468

    Patients

    Seq Age Sex Outcome Treatment
    1