BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA LLL COLONOVIDEOSCOPE

    MDR report key: 12661536 · Received October 19, 2021

    Report

    Report Number
    8010047-2021-13365
    Event Type
    Malfunction
    Date Received
    October 19, 2021
    Date of Event
    August 28, 2021
    Report Date
    December 2, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    UDI-DI
    04953170305177
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER HMI (HYGIENE MICROBIOLOGICAL INVESTIGATION) RESULTS REPORTED THE DEVICE TESTED POSITIVE WITH BACILLUS SPP MESOPHILES 2 UFC AND MICROCOCCACEAE GREATER THAN 100 UFC .(B)(4) FOR HMI (HYGIENE MICROBIOLOGICAL INVESTIGATION) RESULTS AS FOLLOWS: GRAM POSITIVE BACTERIA DETECTED. MICROCOCCACEAE DETECTED. THE RESULTS OBTAINED COMPLY WITH THE TARGET LEVEL DEFINED IN THE DGOS / PF2 / DGS / VSS1 / 2016/220 INSTRUCTION OF JULY 4, 2016. THE RESULTS OBTAINED COMPLY WITH THE TARGET LEVEL DEFINED IN THE REGULATIONS OF (B)(6)OUTLINED ON JULY 4, 2016. THE RESULTS ARE CONFORM TO (B)(6) RECOMMENDATION. THE SUBJECT DEVICE WAS DECONTAMINATED, DISINFECTED AND STERILIZED. THE OPERATIONS WERE CARRIED OUT. RRC (REGIONAL REPAIR CENTER) (B)(4) WILL PROCEED WITH A NORMAL REPAIR IF NECESSARY. BELOW ARE INFORMATION ON CUSTOMERS CDS CHECKLIST: FRANKLAB DDN 9 IS THE DETERGENT USED FOR CLEANING. PERACETIC ACID IS THE DISINFECTANT USED FOR DISINFECTION. AER TREATMENT TYPE-WASSENBURG WD440 ADAPTASCOPE, WASSENBURG ENDOHIGH DETERGENT, WASSENBURG ENDOHIGH PAA. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S INVESTIGATION. INVESTIGATION RESULT: THOUGH IT WAS LOWER THAN THE STANDARD VALUE, SITE BUSINESS CENTER (SBC) (B)(4) OLYMPUS CONFIRMED GROWTH OF MICROORGANISM FROM CULTURE TEST RESULT ON THE SUBJECT DEVICE, PERFORMED BY THE THIRD-PARTY LAB. ·RESULT OF THE CULTURE TEST FROM THE USER: CHANNEL RINSING WATER:>100CFU/ENDOSCOPE >100CFU MICROCOCCACEAE. 2CFU BACILLUS SPP. MESOPHILES (30¿). ·RESULT OF THE CULTURE TEST, PERFORMED BY SBC AFTER REPROCESSING. CHANNEL RINSING WATER:5CFU/ENDOSCOPE GRAM POSITIVE BACTERIA, MICROCOCCACEAE STANDARD VALUE:¿¿5CFU/ENDOSCOPE. CONCLUSION - THE LEVEL OF DETECTED GERMS WAS LOWER THAN THE STANDARD VALUE OF THE LOCAL REGULATION. DEVICE RETURN INSPECTION RESULT: - CONTROL KNOB IS ROUGH TO MOVE BUT THE ANGULATION IS STILL FUNCTIONAL. THE ANGULATION WIRE IS STRETCHED AND CAUSES RESISTANCE. - BIOPSY CHANNEL OPENING/ BIOPSY PORT DAMAGED. - INSUFFICIENT ANGULATION. THERE WAS NO REPORT ON THE SUBJECT DEVICE BEING USED IN PROCEDURE AFTER THE SUGGESTED EVENT WAS CONFIRMED. DHR (DEVICE HISTORY RECORD) REVIEW CONFIRMED THAT THE SUBJECT DEVICE WAS SHIPPED IN ACCORDANCE WITH SPECIFICATIONS. THE SUGGESTED EVENT WAS POSITIVE CULTURE TEST OF THE SUBJECT DEVICE. NONCONFORMITIES OF THE SUBJECT DEVICE WERE CONFIRMED FROM DEVICE RETURN INSPECTION RESULT, HOWEVER, IT CANNOT JUDGE WHETHER THEY AFFECTED THE SUGGESTED EVENT OR NOT. CONCLUSION: IT COULD NOT CONCLUSIVELY SPECIFY THE ROOT CAUSE OF THE SUGGESTED EVENT. THOUGH THE ROOT CAUSE OF THE EVENT WAS NOT SPECIFIED, THE FOLLOWING WERE ASSUMED. - REPROCESSING CONDUCTED BY THE USER WAS DEVIATED FROM THE REPROCESSING RECOMMENDED IN IFU (INSTRUCTION FOR USE). - CONTAMINATION OCCURRED AT MICROBIOLOGICAL SAMPLING. IFU (INSTRUCTION FOR USE) STATES AS FOLLOWS: REPROCESSING MANUAL:1.4 PRECAUTIONS: WARNING: AN INSUFFICIENTLY REPROCESSED ENDOSCOPE AND/OR ACCESSORY MAY POSE AN INFECTION CONTROL RISK TO THE PATIENTS AND/OR OPERATORS WHO TOUCH THEM. OLYMPUS WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS DEVICE.

    Description of Event or Problem · 0

    AS REPORTED, AFTER A MICROBIOLOGICAL ROUTINE CONTROL TEST ON THE SUBJECT MEDICAL DEVICE AS REQUIRED BY (B)(6) REGULATION, THE USER DETECTED AN UNEXPECTED CONTAMINATION. THE ISSUE FOUND DURING REPROCESSING. THE USER THEN SENT THE DEVICE TO THE (B)(4) FOR HMI (HYGIENE MICROBIOLOGICAL INVESTIGATION) FOR FURTHER INVESTIGATION. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY PATIENT INJURY OR PATIENT INFECTION. NO USER INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1553884 EVIS EXERA LLL COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. CF-H190I 04953170305177

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown