BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III COLONOVIDEOSCOPE

    MDR report key: 12537836 · Received September 27, 2021

    Report

    Report Number
    8010047-2021-12354
    Event Type
    Malfunction
    Date Received
    September 27, 2021
    Date of Event
    September 7, 2021
    Report Date
    November 3, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON HMI (HYGIENE MICROBIOLOGICAL INVESTIGATION) OFR ENDOSCOPE MICROBIOLOGICAL TEST RESULTS . THE FOLLOWING SECTIONS WERE UPDATED: G3, G6, H2, H6 AND H10. 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 FRANCE OUTLINED ON JULY 4, 2016. THE RESULTS ARE CONFORM WITH FRENCH RECOMMENDATION. RRC (REGIONAL REPAIR CENTER) FRANCE OLYMPUS WILL PROCEED WITH A NORMAL REPAIR IF NECESSARY. 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 FRANCE OLYMPUS RRC (REGIONAL REPAIR CENTER) DEVICE PHYSICAL EVALUATION, CUSTOMER CDS CHECKLIST AND LEGAL MANUFACTURER'S INVESTIGATION. BELOW ARE INFORMATION ON CUSTOMERS CDS CHECKLIST: FRANKLAB DDN 9 IS THE DETERGENT USED FOR PRE-CLEANING PERACETIC ACID IS THE DISINFECTANT USED FOR DISINFECTION. ALBYN MEDICAL - BEDSIDE PRE-CLEANING PRACTICE AER TREATMENT TYPE- AER MODEL NAME: SOLUSCOPE 4 AER DETERGENT: SOLUSCOPE CLN AER DISINFECTANT: SOLUSCOPE PAA STORAGE PRACTICE: SOLUSCOPE SURESTORE DEVICE SERVICE REPAIR EVALUATION THE FOLLOWING WERE FOUND: ANGULATIONS ARE OUT OF SPECIFICATION. UNIVERSAL CORD HAS WRINKLES. BENDING SECTION RUBBER GLUE CONDITION :FAILED A-RUBBER ADHESIVE WORN OUT. CCD COVER LENS CHIPPED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND THE SUBJECT DEVICE WAS SHIPPED IN ACCORDANCE WITH SPECIFICATIONS. BASED ON THE RESULTS OF THE INVESTIGATION, IT WAS CONFIRMED NO GROWTH OF MICROORGANISM FROM CULTURE TEST ON THE SUBJECT DEVICE PERFORMED BY THE THIRD-PARTY LAB. THERE WAS NO REPORT ON THE SUBJECT DEVICE BEING USED IN PROCEDURE AFTER THE SUGGESTED EVENT WAS CONFIRMED. WE 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. - CONTAMINATION OCCURRED AT MICROBIOLOGICAL SAMPLING. IFU (INSTRUCTION FOR USE) STATES AS FOLLOWS: REPROCESSINGMANUAL: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.

    Additional Manufacturer Narrative · 1

    CUSTOMER HMI (HYGIENE MICROBIOLOGICAL INVESTIGATION) RESULTS REPORTED THE DEVICE TESTED POSITIVE WITH ENTEROBACTER AEROGENES DE PSEUDOMONAS AERUGINOSA. THE SUBJECT DEVICE WAS DECONTAMINATED, DISINFECTED AND STERILIZED. THE OPERATIONS WERE CARRIED OUT. THE SUBJECT DEVICE WAS RETURNED TO (B)(6) RRC (REGIONAL REPAIR CENTER) OLYMPUS SITE FOR PHYSICAL EVALUATION. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    Description of Event or Problem · 1

    AS REPORTED, DURING CUSTOMER PERIODICAL CHECK , AFTER A MICROBIOLOGICAL ROUTINE CONTROL TEST ON THE SUBJECT MEDICAL DEVICE AS REQUIRED BY FRENCH REGULATION, THE USER DETECTED AN UNEXPECTED CONTAMINATION. THE ISSUE FOUND DURING REPROCESSING. THE USER THEN SENT THE DEVICE TO THE FRENCH OLYMPUS SUBSIDIARY 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
    1428992 EVIS EXERA III COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. CF-H185I

    Patients

    Seq Age Sex Outcome Treatment
    1