BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPE, UTEROSCOPE, VIPER

    MDR report key: 3112087 · Received May 2, 2013

    Report

    Report Number
    1418479-2013-00016
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 18, 2013
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Product Code
    FGB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED TO THE RICHARD WOLF FACILITY AND INVESTIGATION COMPLETED (B)(4) 2013. UPON VISUAL AND FUNCTIONAL INSPECTION BY THE OPTICS DEPT, A HOLE WAS FOUND ON THE METAL AREA OF THE DISTAL TIP. WE SEE THIS TYPE OF DAMAGE WHEN THE LASER WIRE IS ACTIVATED WHILE STILL INSIDE OF THE WORKING CHANNEL. THE EDGES OF THE HOLE CAN THEN ACT AS A KNIFE/BURR AND CUT/CATCH ITEMS THAT IT COMES IN CONTACT WITH. THE HOLE MOST LIKELY CAUSED THE TIP OF THE LASER FIBER TO CATCH AND THEN CUT/BREAK WHEN ADVANCING OUT THE TIP OF THE SCOPE. THE ROOT CAUSE OF THE FIBER CATCHING AND BREAKING IS USER ERROR. THE ENTIRE SHAFT MUST BE REPLACED AS IT CAN NOT BE REPAIRED. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE, I.E. INTENDED USE, INDICATIONS AND FIELD OF USE, PREPARATION AND CAUTIONS. RWMIC CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT ADDITIONAL INFORMATION IS RECEIVED, WE WILL PROVIDE FDA WITH FOLLOW-UP INFORMATION.

    Description of Event or Problem · 1

    FACILITY REPORTED THAT THE LASER FIBER TIP WAS "CATCHING" AND ULTIMATELY BROKE OFF WHILE BEING USED WITH THE RICHARD WOLF FLEXIBLE SCOPE. IT WAS ALSO REPORTED THIS INCIDENT OCCURRED WHILE BEING USED ON A PT; HOWEVER, NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191092 ENDOSCOPE, UTEROSCOPE, VIPER UTEROSCOPE FGB RICHARD WOLF MEDICAL INSTRUMENTS CORP. 7325.071 615324

    Patients

    Seq Age Sex Outcome Treatment
    1 Other