BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLONOVIDEOSCOPE

    MDR report key: 13893229 · Received March 24, 2022

    Report

    Report Number
    8010047-2022-04967
    Event Type
    Malfunction
    Date Received
    March 24, 2022
    Report Date
    May 4, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    UDI-DI
    04953170307638
    PMA / PMN Number
    K001241
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RECEIVED AND EVALUATED. THE DEVICE WAS INSPECTED AND FOUND CONNECTING TUBE HAS WRINKLES, SCRATCHES, DISCOLORATION, LOW ANGULATIONS AND FREE PLAY. THE CUSTOMER REPORTED ISSUE WAS CONFIRMED. FURTHER INSPECTION FOUND NOZZLE HAS FOREIGN OBJECTS. ADDITIONALLY, THE FOLLOWING FINDINGS WERE NOTED ON THE DEVICE BELOW: OBJECTIVE LENS HAS A SCRATCH, C-COVER HAS A SCRATCH, C-COVER HAS A DENT, C-COVER IS DIRTY DUE TO ADHESIVE PEELING ON A-RUBBER, CONNECTION BETWEEN BENDING SECTION AND CONNECTING TUBE IS DETACHED. ADHESIVE ON A-RUBBER IS DETACHED. A-RUBBER IS DIRTY, CHIPPED, KNOB DIRTY. CONNECTING TUBE HAS A SCRATCH, A BUCKLING, COATING PEELING, HAS A WRINKLE,S-CONNECTOR HAS A SCRATCH, - SW1 HAS A SCRATCH. CONTROL UNIT HAS A SCRATCH; S-CONNECTOR HAS A SCRATCH,CONTROL UNIT IS DIRTY, GRIP IS DIRTY, AND INDICATION ON GRIP IS PEELED. UNIVERSAL CORD HAS COATING PEELING, SCRATCH, CORD IS DIRTY. PROTECTOR OF UNIVERSAL CORD ON S-CONNECTOR SIDE HAS A SCRATCH. DUE TO DEFORMATION OF BENDING TUBE, BENDING ANGLE IN UP/DOWN/RIGHT/LEFT DIRECTION DOES NOT MEET THE STANDARD VALUE. DUE TO DEFORMATION OF BENDING TUBE, THE PLAY OF U/D / R/L KNOB IS OUT OF THE STANDARD VALUE. DUE TO DAMAGE ON CCD UNIT, THE IMAGE HAS WHITE DOTS, IMAGE HAS BLACK DOTS, THE SPECIFIED RESOLVING POWER IS NOT OBTAINED. CLOGGING OF NOZZLE, WATER REMOVAL ABILITY DOES NOT MEET THE STANDARD VALUE. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO CORRECT THE AWARE DATE OF THE INITIAL MDR FROM FEBRUARY 28, 2022, TO FEBRUARY 22, 2022, AND TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER¿S INVESTIGATION. A REVIEW OF THE INSTRUMENT REPAIR HISTORY SHOWED THAT THE DEVICE HAS NEVER BEEN REPAIRED IN THE PAST. NO INFORMATION REPORTED IN WHICH THE DEVICE WAS USED FOR PROCEDURE WHILE THE FOREIGN OBJECTS CLOGGED THE AIR/WATER NOZZLE, BUT THE POSSIBILITY CANNOT BE DENIED. THE REPORTED EVENT WAS A DEFECT OF THE DEVICE AND NO ADVERSE EVENT REPORTED. A REVIEW OF THE COMPLAINT DATABASE SHOWED NO SIMILAR COMPLAINT OCCURRED WITH THE SAME DEVICE AND THE SAME USER FACILITY; HOWEVER, THERE IS A SIMILAR COMPLAINT THAT WAS REPORTED BY A DIFFERENT USER FACILITY. THE LEGAL MANUFACTURER CANNOT DETERMINE THE ROOT CAUSE OF THE REPORTED EVENT; HOWEVER, FOREIGN OBJECTS SUCH AS ADHERENT OF BODY FLUIDS AND CHEMICAL SOLUTIONS CLOGGED IN NOZZLE BECAUSE OF INAPPROPRIATE REPROCESSING AFTER USE. THE DEVICE HISTORY RECORD WAS REVIEWED AND CONFIRMED THAT THE DEVICE WAS SHIPPED IN ACCORDANCE WITH ITS SPECIFICATIONS. THE USER CAN DECREASE AND PREVENT OCCURRENCE OF THE SUGGESTED EVENT BY HANDLING THE DEVICE IN ACCORDANCE WITH THE FOLLOWING INSTRUCTIONS FOR USE: REPROCESSING MANUAL-PRECLEANING THE ENDOSCOPE AND ACCESSORIES WARNING: IF THE ENDOSCOPE AND ACCESSORIES USED IN THE PATIENT PROCEDURE ARE NOT IMMEDIATELY CLEANED AFTER EACH PATIENT PROCEDURE, RESIDUAL ORGANIC DEBRIS WILL BEGIN TO DRY AND SOLIDIFY, HINDERING EFFECTIVE REMOVAL AND REPROCESSING EFFICACY. PRE-CLEAN THE ENDOSCOPE AND THE ACCESSORIES AT THE BEDSIDE IN THE PATIENT PROCEDURE ROOM IMMEDIATELY AFTER EACH PATIENT PROCEDURE. FLUSH THE AIR/WATER CHANNEL WITH WATER AND AIR. CAUTION: TO PREVENT CLOGGING OF THE AIR/WATER NOZZLE OF THE ENDOSCOPE, FLUSH WATER INTO THE AIR CHANNEL OF THE ENDOSCOPE, USING THE AIR/WATER CHANNEL CLEANING ADAPTER (MH-948) AFTER EACH PATIENT PROCEDURE. MANUALLY CLEANING THE ENDOSCOPE ACCESSORIES: CLEAN THE EXTERNAL SURFACES OF THE INSERTION SECTION, IMMERSE THE ENDOSCOPE IN THE DETERGENT SOLUTION. WITH THE ENDOSCOPE IMMERSED, USE A SOFT BRUSH OR LINT-FREE CLOTH TO THOROUGHLY BRUSH OR WIPE ALL EXTERNAL SURFACES OF THE ENDOSCOPE. PAY PARTICULAR ATTENTION TO THE AIR/WATER NOZZLE OPENING AND THE OBJECTIVE LENS AND ENSURE THAT ALL SURFACES OF THE DISTAL END ARE THOROUGHLY CLEANED. FLUSH THE AIR/WATER CHANNEL WITH DETERGENT SOLUTION. REMOVE DETERGENT SOLUTION FROM ALL CHANNELS. PRESOAKING THE ENDOSCOPE: IF THE THERE WAS EXCESSIVE BLEEDING DURING THE PATIENT PROCEDURE OR IF PRE-CLEANING COULD BE PERFORMED IMMEDIATELY AFTER THE PATIENT PROCEDURE, PRESOAKING THE ENDOSCOPE IN DETERGENT SOLUTION BEFORE MANUALLY CLEANING THE ENDOSCOPE MAY BE REQUIRED TO WET AND LOOSEN DEBRIS THAT HAS DRIED AND HARDENED INTO THE ENDOSCOPE¿S SURFACES. THE DEVICE MASTER RECORD WAS NOT REVIEWED, AS THE REPORTED EVENT WAS NOT DUE TO DESIGN ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE WAS FOUND WITH REDUCED ANGULATION IN ALL DIRECTIONS. THE ISSUE FOUND DURING AN UNKNOWN EVENT. THERE IS NO PATIENT INVOLVEMENT ASSOCIATED ON THIS EVENT. NO USER INJURY REPORTED. DEVICE EVALUATION FOUND THE DEVICE NOZZLE HAS FOREIGN OBJECTS. THIS REPORT IS BEING SUBMITTED FOR FOREIGN OBJECTS FOUND ON THE NOZZLE DURING DEVICE EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797442 COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. CF-Q150L 04953170307638

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown