BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAKAO 3.0 MM SNARE

    MDR report key: 222673 · Received May 6, 1999

    Report

    Report Number
    MW1016272
    Event Type
    Malfunction
    Date Received
    May 6, 1999
    Date of Event
    April 28, 1999
    Report Date
    May 6, 1999
    Manufacturer
    U.S. ENDOSCOPY GROUP, INC.
    Product Code
    FDI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON 4/28/99, WHILE MD WAS DOING A COLONOSCOPY PROCEDURE, THE SLIDING METAL MECHANISM OPERATED BY HAND CONTROL ON DISPOSABLE NAKAO SNARE 3.0MM I, OVAL, BENT AND SNARE WAS INOPERABLE. THIS OCCURRED TWICE MORE (TOTAL OF 3 TIMES) BEFORE A SNARE OPERATED. THERE WAS NO INJURY OR HARM TO THE PT. ON 5/3/99, WHILE PT WAS UNDERGOING SIGMOIDOSCOPY, THE SAME EVENT OCCURRED AS ABOVE (X2). THERE WAS NO INJURY OR HARM TO THE PT. ALL 5 SNARES WERE IMMEDIATELY REMOVED FROM SVC AND SAVED. THE OUTER WRAPPINGS WERE DISCARDED AND WERE UNABLE TO BE RETRIEVED. THE CUSTOMER SVC REP FOR US ENDOSCOPY WAS NOTIFIED BY PHONE ON 4/29/99 AND TWO REPLACEMENT BOXES OF NAKAO SNARE (NEW LOT #) HAVE BEEN RECEIVED. VOLUNTARY FDA REPORT HAS BEEN COMPLETED, AND A COPY OF THESE REPORTS WILL ALSO BE SENT TO THE MFR.

    Description of Event or Problem · 2

    ON 4/28/99, WHILE MD WAS DOING A COLONOSCOPY PROCEDURE, THE SLIDING METAL MECHANISM OPERATED BY HAND CONTROL ON DISPOSABLE NAKAO SNARE 3.0MM I, OVAL, BENT AND SNARE WAS INOPERABLE. THIS OCCURRED TWICE MORE (TOTAL OF 3 TIMES) BEFORE A SNARE OPERATED. THERE WAS NO INJURY OR HARM TO THE PT. ON 5/3/99, WHILE PT WAS UNDERGOING SIGMOIDOSCOPY, THE SAME EVENT OCCURRED AS ABOVE (X2). THERE WAS NO INJURY OR HARM TO THE PT. ALL 5 SNARES WERE IMMEDIATELY REMOVED FROM SVC AND SAVED. THE OUTER WRAPPINGS WERE DISCARDED AND WERE UNABLE TO BE RETRIEVED. THE CUSTOMER SVC REP FOR US ENDOSCOPY WAS NOTIFIED BY PHONE ON 4/29/99 AND TWO REPLACMENT BOXES OF NAKAO SNARES (NEW LOT #) HAVE BEEN RECEIVED. VOLUNTARY FDA REPORT HAS BEEN COMPLETED, AND A COPY OF THESE REPORTS WILL ALSO BE SENT TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAKAO 3.0 MM SNARE DISPOSABLE NAKAO SNARE 1 OVAL FDI U.S. ENDOSCOPY GROUP, INC. 00711075 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other
    2 NA Other