BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAINBOW ENDOSCOPIC CLEANING BRUSH

    MDR report key: 1963671 · Received December 21, 2010

    Report

    Report Number
    3001845648-2010-00026
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Report Date
    November 25, 2010
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MNL
    PMA / PMN Number
    CLASS I N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL LOT NUMBER OF THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT PROVIDED; THEREFORE, IT WAS NOT POSSIBLE TO ESTABLISH IF THERE WERE ANY DEVICES FROM THE AFFECTED LOT NUMBER IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. ONE RCB-180-D DEVICE WAS RETURNED TO COOK (B)(4) FOR EVALUATION. THE DEVICE WAS NOT RETURNED IN ITS ORIGINAL PACKAGING, THEREFORE, THE LOT NUMBER CANNOT BE CONFIRMED. THE CUSTOMER COMPLAINT WAS CONFIRMED ON EVALUATION OF THE RETURNED DEVICE AS ONLY ONE BRUSH HEAD WAS ATTACHED TO THE COILED WIRE/BRUSH SHAFT. RCB-180-D IS A DOUBLE ENDED BRUSH. ONE OF THE BRUSH HEADS HAD BROKEN OFF. THE BRUSH HEAD WHICH HAD BROKEN OFF FROM THE END OF THE BRUSH SHAFT WAS ALSO RETURNED. THE BRUSH BROKE DURING CLEANING OF THE ENDOSCOPE. IT IS POSSIBLE THAT EXCESS FORCE MAY HAVE BEEN APPLIED. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED AS WE WERE UNABLE TO REPLICATE THE CONDITIONS OF USE IN THE LABORATORY. PRIOR TO DISTRIBUTION ALL RCB-180-D RAINBOW ENDOSCOPIC CLEANING BRUSHES ARE SUBJECTED TO INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR RCB-180-D DEVICE INVOLVED IN THIS COMPLAINT COULD NOT BE REVIEWED AS THE LOT NUMBER WAS NOT PROVIDED. 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. NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME AS THE RAINBOW ENDOSCOPIC CLEANING BRUSH IS USED FOR CLEANING UPPER AND LOWER GI ENDOSCOPES; THERE IS NO CONTACT WITH PATIENTS, THEREFORE, THERE IS NO IMPACT TO THE PATIENT. FROM THE INFORMATION RECEIVED TO-DATE, THIS COMPLAINT REPORT DID NOT IMPACT THE PATIENT OR END USER.

    Description of Event or Problem · 1

    THE BRUSH HEAD OF THE ENDOSCOPE CLEANING BRUSH BROKE OFF DURING CLEANING. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAINBOW ENDOSCOPIC CLEANING BRUSH MNL ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPES MNL COOK IRELAND LTD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1