BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE COMBINATION CLEANING BRUSH

    MDR report key: 13264753 · Received January 17, 2022

    Report

    Report Number
    8010047-2022-01531
    Event Type
    Malfunction
    Date Received
    January 17, 2022
    Report Date
    July 1, 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
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. SINCE THE DEVICE LOT NUMBER, THE DELIVERY DATE, THE DATE OF OCCURRENCE WERE UNKNOWN, THE DEVICE HISTORY RECORD (DHR) FOR OVER THE PAST YEAR PRIOR TO THE AWARE DATE WAS INSPECTED. NO ABNORMALITIES OR DEVIATIONS WERE FOUND THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT THIS PHENOMENON OCCURRED DUE TO THE FOLLOWING: 1. REGARDING CLEANING EQUIPMENT WITH ADHESION OF DIRT AND FOREIGN MATERIALS MANUFACTURED BY OTHER COMPANY: IT IS POSSIBLE THAT ABNORMALITIES OF BW-412T WERE NOT THE CAUSE OF THE REPORTED EVENT. LACK OF RINSING MIGHT HAVE CONTRIBUTED TO THE ADHESION OF DIRT AND FOREIGN MATERIALS. 2. REGARDING LACK OF STIFFNESS OF THE SHEATH: IT WAS DETERMINED THE PHENOMENON WAS REPORTED BASED ON USER¿S PREFERENCES, AND IT WAS NOT ABOUT PRODUCT ABNORMALITIES. A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED. THE INSTRUCTIONS FOR USE (IFU) INSTRUCTION MANUAL STATE: - IFU WARNS AGAINST THIS EVENT AS FOLLOWS: - ¿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.¿ - "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." OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    ON DECEMBER 23, 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY A BIOMEDICAL ENGINEER THAT DURING PRE-CLEANING, A NEW OLYMPUS ENDOSCOPE WAS WASHED USING A BRUSH MANUFACTURED BY NON-OLYMPUS NOT BY OLYMPUS (BW-412T). THEN, A FOREIGN BODY WAS OUT FROM THE ENDOSCOPE. THERE WAS NO PATIENT INJURY REPORTED. IT WAS CONCERNED THAT IT MIGHT HAVE BEEN USED FOR INSPECTIONS IN A STATE OF INSUFFICIENT CLEANING. THE CLEANING BRUSHES USED IN THE ENDOSCOPY ROOM AND THE MEDICAL EXAMINATION CENTER WERE DIFFERENT, AND THE BIOMEDICAL ENGINEER WAS DISSATISFIED WITH THE WEAKNESS OF THE SHEATH OF BW-412T USED IN THE ENDOSCOPY ROOM. THE BIOMEDICAL ENGINEER TRIED USING A BRUSH MANUFACTURED BY NON-OLYMPUS NOT BW-412T AT THE MEDICAL EXAMINATION CENTER. WHEN THE BIOMEDICAL ENGINEER TRIED USING THE BRUSH, A FOREIGN OBJECT CAME OUT FROM THE FORCEPS CHANNEL. ON DECEMBER 28. 2021, OMSC WAS INFORMED BY A CLINICAL ENGINEER THAT THE EVENT OCCURRED MORE THAN A MONTH BEFORE DECEMBER 28TH. IT WAS CERTAIN THAT THE ENDOSCOPE WAS A LOWER DIGESTIVE ORGAN SCOPE, BUT THE CLINICAL ENGINEER FORGOT THE MODEL NAME AND THE SERIAL NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1331501 SINGLE USE COMBINATION CLEANING BRUSH SINGLE USE SINGLE-ENDED CLEANING BRUSH MNL OLYMPUS MEDICAL SYSTEMS CORP. BW-412T 04953170297427

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown