BEUDAMED
    FDA Adverse Event Other Summary report: N

    CUSTOM ULTRASONICS

    MDR report key: 980676 · Received December 30, 2005

    Report

    Report Number
    980676
    Event Type
    Other
    Date Received
    December 30, 2005
    Date of Event
    April 12, 2004
    Report Date
    September 29, 2004
    Manufacturer
    CUSTOM ULTRASONICS
    Product Code
    FLG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    STAFF DISCOVERED A PROBLEM WITHIN SOME OF THE CONNECTIONS TO THE PORTS OF THE SCOPE. ALTHOUGH, WE HAD ALWAYS USED TERGEL PRODUCT, THE O-RINGS OCCLUDED THE FLOW OF SOLUTION THROUGH LUMENS. THIS ALLOWED IMPROPERLY REPROCESSED SCOPES TO BE USED FOR PROCEDURES. STAFF FOLLOWED THE MANUFACTURERS RECOMMENDED STEPS FOR SCOPE RE-PROCESSING FOLLOWING A THROUGH MANUAL CLEANING PROCESS WITH TERGEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM ULTRASONICS SCOPE WASHER FLG CUSTOM ULTRASONICS 020598 *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other