BEUDAMED
    FDA Adverse Event Summary report: N

    TORRENT IRRIGATION TUBING

    MDR report key: 4254842 · Received November 13, 2014

    Report

    Report Number
    1528319-2014-00022
    Date Received
    November 13, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 15, 2014
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP, INC.
    Product Code
    OCX
    PMA / PMN Number
    K103239
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE TORRENT IRRIGATION TUBING IS USED IN THE DELIVERY OF STERILE WATER TO THE ENDOSCOPE. THE TORRENT IRRIGATION TUBING CONNECTS THE STERILE WATER SOURCE TO OTHER DEVICES WHICH ATTACH TO OTHER AUXILIARY WATER CHANNEL OF THE ENDOSCOPE. THE PROXIMAL END OF THE TORRENT TUBING INCLUDES A LID CAP, FOR ATTACHMENT TO A WATER BOTTLE. THE DISTAL END OF THE TUBING INCLUDES A MALE LUER LOCK CONNECTOR WITH A ONE WAY VALVE, FOR ATTACHMENT OTHER CONNECTING DEVICES. THE DEVICE WAS NOT RETURNED, CONSEQUENTLY THERE WAS NO PHYSICAL EXAMINATION OF THE DEVICE. THE LOT NUMBER WAS UNKNOWN, CONSEQUENTLY THERE WAS NO REVIEW OF THE MANUFACTURING RECORD. A REVIEW OF COMPLAINT HISTORY FINDS NO SIMILAR COMPLAINT OF LEAKAGE UPON DISCONNECTION OF THE DEVICE. DEVICE LEAKAGE COULD NOT BE REPLICATED THROUGH SIMULATED USE TESTING. HOWEVER, THE CUSTOMER WILL BE PROVIDED WITH IN-SERVICE INSTRUCTION TO ADDRESS THE LEAKAGE ISSUE. THIS REPORT WILL BE UPDATED IF FURTHER INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    US ENDOSCOPY RECEIVED REPORT OF WATER LEAKING ONTO THE FLOOR AFTER DETACHING THE TORRENT IRRIGATION TUBING ((B)(4)) FROM A CONNECTOR TUBING SET. THE CUSTOMER REPORTED USING A CAP WITH THE TUBING TO PREVENT WATER LEAKAGE AND REPORTED THE FLOOR WAS SLIPPERY DUE TO USE OF AN ANTI-FOAMING AGENT. THE WATER LEAKAGE RESULTED IN USER FALLS ON TWO DIFFERENT OCCASIONS. THE USERS DID NOT RECEIVE MEDICAL TREATMENT. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733749 TORRENT IRRIGATION TUBING IRRIGATION TUBING OCX UNITED STATES ENDOSCOPY GROUP, INC. 00711561 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other