BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORRENT IRRIGATION TUBING

    MDR report key: 3030784 · Received March 27, 2013

    Report

    Report Number
    1528319-2013-00026
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 27, 2013
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO THE RISK OF INJURY FROM SLIPPING OR FALLING FROM EXCESS WATER ON THE FLOOR USE IS SUBMITTING THIS MDR. BASED ON THE INFORMATION PROVIDED, THERE WAS NO INJURY TO EITHER PATIENT OR USER.

    Description of Event or Problem · 1

    THE DEVICE IS CONNECTED TO SPECIFIED TUBING AND ACCESSORIES AND IS USED TO PROVIDE IRRIGATION DURING ENDOSCOPIC PROCEDURES. IT WAS REPORTED THAT DURING A PROCEDURE A SIGNIFICANT AMOUNT OF FLUID LEAKED FROM THE JUNCTION POINT BETWEEN THE BLUE LUER LOCK AND THE TUBING. THERE WAS NO REPORTED HARM TO PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125273 TORRENT IRRIGATION TUBING IRRIGATION TUBING GCJ UNITED STATES ENDOSCOPY GROUP, INC. 711560 82942

    Patients

    Seq Age Sex Outcome Treatment
    1