BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUASHIELD WATER BOTTLE SYSTEM

    MDR report key: 2820216 · Received October 31, 2012

    Report

    Report Number
    1528319-2012-00020
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 31, 2012
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP, INC.
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO PROVIDED, NO INJURY OCCURRED. IN ADDITION, THE ACTUAL DEVICE INVOLVED WAS NOT RETURNED FOR INVESTIGATION. REVIEW OF THE LOT HISTORY ROUTER INDICATES NO PROBLEMS IN THE MANUFACTURING OF THIS DEVICE. COMPLAINT 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 USED WITH AN AIR SOURCE TO SUPPLY STERILE WATER TO AN ENDOSCOPE DURING ENDOSCOPIC PROCEDURES. A CUSTOMER REPORTED DURING A PROCEDURE A SIGNIFICANT AMOUNT OF WATER LEAKED AT THE CONNECTION BETWEEN THE ENDOSCOPE AND THE DEVICE. THERE WAS NO REPORT HARM TO PT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUASHIELD WATER BOTTLE SYSTEM WATER BOTTLE SYSTEM KOG UNITED STATES ENDOSCOPY GROUP, INC. 711540 73462

    Patients

    Seq Age Sex Outcome Treatment
    1