BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA LLL COLONOVIDEOSCOPE

    MDR report key: 10933771 · Received December 2, 2020

    Report

    Report Number
    8010047-2020-09709
    Event Type
    Malfunction
    Date Received
    December 2, 2020
    Date of Event
    November 4, 2020
    Report Date
    January 16, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    UDI-DI
    04953170305153
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION, BUT WAS RETURNED TO OLYMPUS AUSTRALIA (OAZ). OAZ REPAIRED THE SUBJECT DEVICE AND SENT BACK TO THE USER FACILITY. THE USER FACILITY CONDUCTED MICROBIOLOGICAL CULTURING TEST, BUT OAZ COULD NOT OBTAIN THE TEST RESULT. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, BASED UPON THE INSPECTION BY OAZ, THERE IS THE POSSIBILITY THAT THE SUBJECT DEVICE HAD BEEN USED WITHOUT SUFFICIENT MAINTENANCE AND/OR APPROPRIATE CHECK. THE INSTRUCTIONS FOR USE OF THE SUBJECT DEVICE DESCRIBES THAT ¿USE OF A LEAKING ENDOSCOPE MAY ALSO POSE AN INFECTION CONTROL RISK¿ AND ¿DO NOT USE THE EQUIPMENT IF ANY IRREGULARITY IS FOUND¿ AS WARNINGS.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICES HAVE NOT BEEN RETURNED TO OMSC BUT WERE RETURNED TO OLYMPUS (B)(4) FOR EVALUATION. IN THE EVALUATION OF (B)(4) THE FOLLOWING WAS CONFIRMED; THE INSTRUMENT CHANNEL HAD LEAKAGE. THE ANGULATION CONTROL KNOB HAD LEAKAGE. THE DISTAL END INSULATION TEST HAD FAILED. THE BENDING ANGLE DID NOT MEET SPECIFICATION. THE ANGULATIONS WERE SLACK AND HEAVY DUE TO THE WORN OF THE BENDING TUBE AND THE ANGULATIONS WIRES. THE ANGULATION CONTROL KNOB COULD NOT BE LOCKED CORRECTLY. THE OBJECTIVE LENS HAD BEEN CHIPPED OR CRACKED. THE LIGHT GUIDE LENS HAD BEEN CHIPPED OR CRACKED. THE DISTAL END COVER HAD BEEN SCRATCHED OR DENTED. THE BENDING RUBBER ADHESIVE HAD BEEN DETACHED, CHIPPED, CRACKED, OR HAD BURR. THE INSERTION TUBE HAD WRINKLES AND SCRATCHES. THE AIR/WATER CYLINDER PORT HAD BEEN LOOSE. THE UNIVERSAL CORD HAD BEEN BUCKLED OR WRINKLED. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT AS A RESULT OF MICROBIOLOGICAL TESTING BY THE USER FACILITY, FOLLOWING MICROBES WERE DETECTED FROM THE SAMPLE COLLECTED FROM THE SUBJECT DEVICE. E. COLI (3 CFU). OTHER DETAILED INFORMATION SUCH AS THE REPROCESSING METHOD WAS NOT PROVIDED. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1402069 EVIS EXERA LLL COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. CF-H190L 04953170305153

    Patients

    Seq Age Sex Outcome Treatment
    1