BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE COMBINATION CLEANING BRUSH

    MDR report key: 12848023 · Received November 19, 2021

    Report

    Report Number
    8010047-2021-14839
    Event Type
    Malfunction
    Date Received
    November 19, 2021
    Report Date
    April 8, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    MNL
    UDI-DI
    04953170297427
    PMA / PMN Number
    CLASS1-EXMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE LOT NUMBER WAS NOT PROVIDED AND THE SUBJECT DEVICE MANUFACTURE DATE COULD NOT BE IDENTIFIED. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THE LOTS 0YV THROUGH 1XV. THE REVIEW REVEALED THE LOTS HAD PASSED ALL THE INSPECTIONS RELATING TO THE REPORTED INCIDENT. BASED ON THE RESULTS OF THE LEGAL MANUFACTURER'S INVESTIGATION, A ROOT CAUSE COULD NOT BE IDENTIFIED. THE CAUSE OF THE PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED BECAUSE THE SUBJECT DEVICE WAS NOT SENT BACK FOR INVESTIGATION. HOWEVER, THE ERROR IS LIKELY RELATED TO THE USE OF NON-OLYMPUS VALIDATED DEVICE AND INAPPROPRIATE REPROCESSING METHODS. THE INSTRUCTION MANUAL IDENTIFIES THE FOLLOWING RELATED VERBIAGE WHICH COULD HAVE PREVENTED THE PHENOMENON: ¿GK7732 REV.11: BEFORE USE, INSPECT THE ENTIRE INSTRUMENT FOR ANY IRREGULARITY AND THE BRISTLES FOR ANY DAMAGE. USING A BRUSH WITH IRREGULARITIES AND/OR DAMAGE CAN IMPAIR ITS CLEANING ABILITY, WHICH MAY CAUSE INFECTION OF THE PATIENT. IF THE BRISTLES ARE CRUSHED, GENTLY STRAIGHTEN THEM WITH YOUR FINGERS. AFTER USING, CAREFULLY CHECK THAT NO PARTS OF THE BRUSH HAVE FALLEN OFF INSIDE THE ENDOSCOPE'S SUCTION CHANNEL. IF THIS INSPECTION DETERMINES THAT A PART OR PARTS OF THE BRUSH HAVE COME OFF DURING CLEANING, IMMEDIATELY RETRIEVE THEM BY PASSING A NEW INSTRUMENT OR OTHER ENDO THERAPY ACCESSORY THROUGH THE CHANNEL. ANY PART OF THE BRUSH REMAINING IN THE CHANNEL AFTER CLEANING CAN DROP INTO THE PATIENT'S BODY DURING A SUBSEQUENT PROCEDURE. DEPENDING ON THE LOCATION OF A DETACHED PART, IT MAY NOT BE RECOVERABLE BY PASSING A NEW INSTRUMENT OR OTHER ENDO THERAPY ACCESSORY THROUGH THE ENDOSCOPE'S SUCTION CHANNEL. IN THIS CASE, CONTACT OLYMPUS. IF THE ENDOSCOPE WHICH HAS FORCEPS ELEVATOR, TURN THE ELEVATOR CONTROL LEVER TO SET THE FORCEPS ELEVATOR BESIDE THE SIDE WALL AREA OF THE DISTAL END AS SHOWN IN FIGURE 1 ( MARKING). OTHERWISE, IT MAY DAMAGE THE ENDOSCOPE AND/OR THE INSTRUMENT. CLEAN ONLY ONE ENDOSCOPE WITH THIS INSTRUMENT AND DISCARD THE BRUSH IMMEDIATELY AFTER USE. OTHERWISE, THE CLEANING EFFECTIVENESS OF THE INSTRUMENT MAY BE IMPAIRED, EQUIPMENT DAMAGE AND/OR INFECTION OF THE PATIENT AND/OR OPERATOR MAY OCCUR. THIS INSTRUMENT IS INTENDED FOR SINGLE USE. DO NOT ATTEMPT TO USE THIS INSTRUMENT TO CLEAN MULTIPLE ENDOSCOPES.¿ ¿3.1 COMPATIBILITY SUMMARY: THE ENDOSCOPE AND ACCESSORIES ARE COMPATIBLE WITH SEVERAL METHODS OF REPROCESSING. REPROCESSING WITH INCOMPATIBLE METHODS CAN CAUSE EQUIPMENT DAMAGE EVEN IF THE NUMBER OF REPROCESSING CYCLES IS SMALL. FOR APPROPRIATE REPROCESSING METHODS, SEE TABLE 3.1 TO 3.4.¿ OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    IN SPEAKING WITH THE OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS), THE CUSTOMER STATED A NON-OLYMPUS CLEANING BRUSH WAS USED DURING PRECLEANING OF THE SCOPE IN ADDITION TO THE VALIDATED PRE-CLEANING PROCESS. THE BRUSH BRISTLES WERE STUCK BETWEEN THE ELEVATOR AND ELEVATOR WALL. THE CUSTOMER USED AN OLYMPUS CLEANING BRUSH DURING MANUAL CLEANING AND STATED OCCASIONALLY THERE WERE BRISTLES LEFT AFTER BRUSHING THE SCOPE BUT WAS NOT SURE IF DURING MANUAL CLEANING OR PRE-CLEANING. THE ENDOSCOPY SUPPORT SPECIALIST (ESS) BRUSHED THE DISTAL END OF SCOPE WITH AN OLYMPUS CHANNEL OPENING CLEANING BRUSH AND COULD NOT DUPLICATE THE BRUSH BRISTLES BEING LEFT IN SCOPE. THE OLYMPUS SALES REPRESENTATIVE INITIALLY ALERTED THE ESS OF THE ISSUE. THE CUSTOMER WAS ADVISED TO NOT USE THIRD PARTY CLEANING BRUSHES DURING PRE-CLEANING AND ONLY USE AN OLYMPUS CLEANING BRUSH DURING REPROCESSING. THE SUBJECT DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED FOR EVALUATION. THEREFORE, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED, IF ADDITIONAL OR SIGNIFICANT INFORMATION BECOMES AVAILABLE AT A LATER TIME. DATE OF EVENT: EXACT DATE UNKNOWN, DATE RANGE PROVIDED AS (B)(6) 2021.

    Description of Event or Problem · 0

    THE OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THE OLYMPUS SINGLE-USE COMBINATION CLEANING BRUSH WAS USED DURING MANUAL CLEANING OR PRECLEANING AND OCCASIONALLY THERE WERE BRISTLES LEFT AFTER BRUSHING THE EVIS EXERA III DUODENOVIDEOSCOPE. THE ISSUE OCCURRED WITH FOUR (4) OLYMPUS SINGLE-USE COMBINATION CLEANING BRUSHES OVER A PERIOD OF TIME. THE ISSUE WAS FOUND AT REPROCESSING. NO PATIENT HARM REPORTED. ADDITIONALLY, IT WAS REPORTED, NON-OLYMPUS CLEANING BRUSH BRISTLES WERE PRESENT IN THE DISTAL END OF THE EVIS EXERA III DUODENOVIDEOSCOPE AND WERE STUCK BETWEEN THE ELEVATOR AND ELEVATOR WALL. THE ISSUE OCCURRED WITH THREE (3) ADDITIONAL EVIS EXERA III DUODENOVIDEOSCOPES OVER A PERIOD OF TIME. THE SCOPES AND BRUSHES WERE INSPECTED PRIOR TO USE WITH NO ISSUES FOUND. THIS COMPLAINT IS RELATED TO PATIENT IDENTIFIERS (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1740076 SINGLE USE COMBINATION CLEANING BRUSH SINGLE USE SINGLE-ENDED CLEANING BRUSH MNL OLYMPUS MEDICAL SYSTEMS CORP. BW-412T UNKNOWN 04953170297427

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown