BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REACH OVERTUBE

    MDR report key: 4110178 · Received September 11, 2014

    Report

    Report Number
    1528319-2014-00017
    Event Type
    Malfunction
    Date Received
    September 11, 2014
    Date of Event
    August 6, 2014
    Report Date
    August 9, 2014
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP
    Product Code
    FED
    PMA / PMN Number
    K100081
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REACH OVERTUBE IS INDICATED FOR USE TO AID THE INSERTION, ADVANCEMENT AND REMOVAL OF APPROPRIATELY SIZED ENDOSCOPES AND ENDOSCOPIC DEVICES DURING DIAGNOSTIC AND THERAPEUTIC ENDOSCOPIC PROCEDURES IN THE UPPER GASTROINTESTINAL TRACT, INCLUDING THE SMALL INTESTINE. THE DEVICE INCLUDES AN EMBEDDED COIL WIRE FOR RADIAL REINFORCEMENT OF THE TUBE ASSEMBLY AND A NON-REINFORCED DISTAL TAPER TIP, FOR USE WITH ENDOSCOPES OF INSERTION TUBE OUTER DIAMETER 10.5-11.7MM. FOLLOW UP COMMUNICATION CONFIRMED THERE WAS NO PATIENT HARM, AND RESULTED IN NO ADDITIONAL INFORMATION CONCERNING THE PROCEDURE OR TYPE OF ENDOSCOPE.

    Description of Event or Problem · 1

    THE REINFORCEMENT COILS FOUND ON REACH OVERTUBE ((B)(4)) WERE REPORTED TO HAVE BECOME MISALIGNED DURING THE DEVICE USE IN AN ERCP PROCEDURE. THE USER REPORTED THERE WAS NO HARM TO THE PATIENT, HOWEVER THE PROCEDURE WAS INTERRUPTED. THE DEVICE WAS NOT RETURNED FOR EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562997 REACH OVERTUBE OVERTUBE FED UNITED STATES ENDOSCOPY GROUP 00712140 1322809

    Patients

    Seq Age Sex Outcome Treatment
    1