BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORRENT IRRIGATION TUBING

    MDR report key: 2820241 · Received October 31, 2012

    Report

    Report Number
    1528319-2012-00017
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 31, 2012
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO PROVIDED, THERE WAS NO INJURY TO EITHER PT OR USER COMPLYING WITH (B)(4) AND (B)(4) TECHNICAL GUIDELINES REQUIRES THE FACILITY TO PROVIDE, AND WEAR, APPROPRIATE PROTECTIVE EQUIPMENT WOULD ALSO MITIGATE ANY POTENTIAL FOR HARM. REVIEW OF THE IMPLANT TRENDING DATA FOR THE DEVICE SHOWS NO REPORTS OF SIMILAR INCIDENTS WITH THE SAME LOT NUMBER.

    Description of Event or Problem · 1

    THE DEVICE IS CONTACTED TO SPECIFIED TUBING AND ACCESSORIES AND IS USED TO PROVIDE IRRIGATION DURING ENDOSCOPIC PROCEDURES. IT WAS REPORTED THAT DURING A COLONOSCOPY PROCEDURE A SIGNIFICANT AMOUNT OF STERILE WATER LEAKED FROM THE DEVICE AND SPRAYED ONTO THE DOCTOR'S LAB COAT. THIS LEAKAGE OCCURRED AT THE ONE WAY VALVE ON THE TUBING. THE CUSTOMER REMOVED THE TUBING AND REPLACED IT WITH ANOTHER WITHOUT ANY FURTHER ISSUES. THERE WAS NO REPORTED HARM TO PT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TORRENT IRRIGATION TUBING IRRIGATION TUBING GCJ UNITED STATES ENDOSCOPY GROUP, INC. 711560 74154

    Patients

    Seq Age Sex Outcome Treatment
    1