BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE ENDOSCOPIC CLEANING BRUSH SET

    MDR report key: 1051642 · Received May 22, 2008

    Report

    Report Number
    3001845648-2008-00001
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    April 28, 2008
    Report Date
    April 28, 2008
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MNL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: AS THE CLEANING BRUSH INVOLVED IN THE REPORT WAS NOT RETURNED FOR EVAL; THE REPORTED OCCURRENCE COULD NOT BE CONFIRMED. A REVIEW OF THE MFG RECORDS COULD NOT BE CARRIED OUT AS THE LOT # OF THE CLEANING BRUSH INVOLVED IN THE REPORT IS UNK. AFTER A REVIEW OF THE ACCOUNT ORDER HISTORY, THE LOT # OF THE CLEANING BRUSH COULD NOT BE DETERMINED. A REVIEW OF THE 2-YR COMPLAINT HISTORY FOR THIS PROD FAMILY WAS CONDUCTED. THIS TYPE OF REPORT REPRESENTS AN UNUSUAL OCCURRENCE. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS REMOTE. CONCLUSION: A FULL INVESTIGATION COULD NOT BE PERFORMED BECAUSE THE CLEANING BRUSH WAS NOT RETURNED FOR EVAL. 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 PT. THE CLEANING BRUSH IS SUPPLIED NON-STERILE AND IS DISPOSABLE - INTENDED FOR SINGLE USE ONLY. THE MAKE AND MODEL OF THE ENDOSCOPE THAT THE DCB-DV-50 CLEANING BRUSH WAS BEING USED TO CLEAN IS UNK AT THIS TIME, THEREFORE WE CANNOT DETERMINE IF CLEANING BRUSH IS COMPATIBLE WITH THE ENDOSCOPE. IF THE CLEANING BRUSH WAS USED TO CLEAN AN ENDOSCOPE THAT IS NOT COMPATIBLE WITH THE CLEANING BRUSH, THIS COULD HAVE CREATED RESISTANCE DURING THE CLEANING PROCESS. IF EXCESSIVE PRESSURE WAS APPLIED TO THE CLEANING BRUSH, PERHAPS IN RESPONSE TO RESISTANCE, THIS COULD HAVE CONTRIBUTED TO BRUSH DETACHMENT INSIDE THE ACCESSORY CHANNEL OF THE ENDOSCOPE. PRIOR TO DISTRIBUTION, ALL DISPOSABLE ENDOSCOPIC CLEANING BRUSHES ARE SUBJECTED TO VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME BECAUSE THIS REPORT WAS UNABLE TO BE VERIFIED. THIS OBSERVATION REPRESENTS AN UNUSUAL OCCURRENCE. THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS REMOTE. CUSTOMER QA WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    THE TIP OF THE CLEANING BRUSH BROKE OFF AND GOT STUCK IN THE ACCESSORY CHANNEL OF THE ENDOSCOPE. THE ENDOSCOPE WAS THEN USED FOR A PROCEDURE RESULTING IN THE BRUSH HEAD ENDING UP INSIDE THE PT. THE BRUSH TIP WAS REMOVED FROM THE PT WITH A POLYPECTOMY SNARE. THE PT HLTH IS PRESENTLY GOOD AND HAS HAD NO PROBLEMS AS A RESULT OF THIS INCIDENT. THE PT DID NOT UNDERGO ANY ADD'L PROCEDURES DUE TO THIS OCCURRENCE, AND THERE WERE NO ADVERSE EFFECTS ON THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention