BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS SINGLE USE CHANNEL CLEANING BRUSH

    MDR report key: 1925080 · Received November 23, 2010

    Report

    Report Number
    8010047-2010-00235
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 25, 2010
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO GATHER ADD'L INFO REGARDING THE REPORTED EVENT. OLYMPUS WAS INFORMED THAT FOLLOWING AN EARLIER PROCEDURE, WHILE A TECHNICIAN WAS CLEANING THE GASTROVIDEOSCOPE, THE TECHNICIAN NOTICED THAT THE DISTAL END OF THE CLEANING BRUSH WAS MISSING. THE TECHNICIAN REPORTEDLY "BLEW OUT" THE CHANNEL AND BELIEVED THE CHANNEL WAS CLEAR. THE DEVICE WAS THEN PROCESSED IN THE USER FACILITY'S AUTOMATIC ENDOSCOPE REPROCESSOR (AER). DURING THE FOLLOWING PROCEDURE, THE BRUSH FELL INTO THE PT. THE BRUSH WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING THE SAME ENDOSCOPE. THERE WAS NO PT INJURY REPORTED. THE ENDOSCOPE WAS NOT RETURNED FOR EVAL, HOWEVER, THE USER FACILITY RETURNED A PORTION OF THE DISTAL END OF A SMALL CLEANING BRUSH THAT WAS BENT INTO A "V" SHAPE. THE BRUSH WAS RECEIVED WITH BIOMATERIAL PRESENT, WHICH LIMITED THE EVAL TO VISUAL EXAMINATION ONLY. THE DEVICE WAS FORWARDED TO THE ORIGINAL EQUIPMENT MFR FOR ADD'L INVESTIGATION. OLYMPUS IS FOLLOWING UP WITH THE USER FACILITY TO OFFER TRAINING REGARDING THE APPROPRIATE REPROCESSING OF ENDOSCOPES. IF SIGNIFICANT ADD'L INFO BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT AT THE BEGINNING OF AN UNSPECIFIED ENDOSCOPIC PROCEDURE, THE DISTAL END OF A CLEANING BRUSH FELL OUT OF THE ENDOSCOPE AND INTO THE PT'S ESOPHAGUS. THE BRUSH WAS RETRIEVED BY UNK MEANS, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS SINGLE USE CHANNEL CLEANING BRUSH CLEANING BRUSH FDX OLYMPUS MEDICAL SYSTEMS CORPORATION BW-201T UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 MODEL GIF-Q180| OLYMPUS EVIS EXERA II GASTROVIDEOSCOPE| (B)(4)