BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE ENDOSCOPIC CLEANING BRUSH SET DOUBLE ENDED CHAN

    MDR report key: 1326087 · Received January 16, 2009

    Report

    Report Number
    3001845648-2009-00003
    Event Type
    Malfunction
    Date Received
    January 16, 2009
    Date of Event
    November 24, 2008
    Report Date
    December 22, 2008
    Manufacturer
    IRL
    Product Code
    MNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE CLEANING BRUSH INVOLVED IN THE REPORT WAS NOT RETURNED FOR EVALUATION; THE REPORTED OCCURRENCE COULD NOT BE CONFIRMED. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CARRIED OUT AS THE LOT NUMBER OF THE CLEANING BRUSH INVOLVED IN THE REPORT IS UNKNOWN. AFTER A REVIEW OF THE ACCOUNT ORDER HISTORY, THE LOT NUMBER OF THE CLEANING BRUSH COULD NOT BE DETERMINED. A REVIEW OF THE 2-YEAR COMPLAINT HISTORY FOR THIS PRODUCT FAMILY WAS CONDUCTED. THIS TYPE OF REPORT REPRESENTS AN UNUSUAL OCCURRENCE. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS REMOTE. A FULL INVESTIGATION COULD NOT BE PERFORMED BECAUSE THE CLEANING BRUSH WAS NOT RETURNED FOR EVALUATION. THE CAUSE OF THE REPORT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, WE CAN PROVIDE THE FOLLOWING COMMENTS: THE DISPOSABLE ENDOSCOPIC CLEANING BRUSH IS USED FOR CLEANING THE ACCESSORY CHANNELS OF ENDOSCOPES BETWEEN USES AND THE CLEANING BRUSH IS NOT A MEDICAL DEVICE USED ON A PATIENT. THE CLEANING BRUSH IS SUPPLIED NON-STERILE AND IS DISPOSABLE - INTENDED FOR SINGLE USE ONLY. PRIOR TO DISTRIBUTION, ALL DISPOSABLE ENDOSCOPIC CLEANING BRUSHES ARE SUBJECTED TO VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME BECAUSE THIS REPORT WAS UNABLE TO BE VERIFIED. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    CLEANING BRUSH HEAD DETACHED INSIDE COLONOSCOPE. TWO INCIDENTS HAPPENED WITHIN A 24 HOUR PERIOD. NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE ENDOSCOPIC CLEANING BRUSH SET DOUBLE ENDED CHAN MNL ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPES MNL IRL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA