BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA LLL COLONOVIDEOSCOPE

    MDR report key: 13589397 · Received February 24, 2022

    Report

    Report Number
    8010047-2022-03484
    Event Type
    Malfunction
    Date Received
    February 24, 2022
    Report Date
    February 24, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    UDI-DI
    04953170305115
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION REGARDING THIS EVENT WAS OBTAINED THROUGH THE INVESTIGATION. DUE TO THE BROKEN PULL ROD IN THE ETD, THE ADAPTER PLATE WITH THE CONNECTED ENDOSCOPE WOULD NOT PULL INTO THE ETD MACHINE¿S BASKET COUPLING. AS A RESULT, THE DETECTION OF THE INSERTED ENDOSCOPE VIA THE LEAK TESTER WAS NOT POSSIBLE. ADDITIONALLY, THE INSERTED ENDOSCOPES WERE NOT RECOGNIZED BY THE RADIO FREQUENCY IDENTIFICATION SYSTEM (RFID) OF THE MACHINE ACCORDING TO THE USER AND THE RFID IDENTIFICATION WAS TURNED ON AT THE TIME. AS A RESULT, THE ETD WAS UNABLE TO DETECT, DURING THE REPROCESSING PROCESS, IF AN ENDOSCOPE HAD BEEN INSERTED. DURING THE REPROCESSING PROCESS, THE MACHINE THEREFORE CORRECTLY DISPLAYED THE USER NOTIFICATION ¿NO ENDOSCOPE¿ MULTIPLE TIMES. THIS WAS ALSO DOCUMENTED IN DIFFERENT STEPS OF THE REPROCESSING PROCESS (RFID ENDOSCOPE RECOGNITION, LEAKAGE TEST, FLOW CONTROL TEST). THE OLYMPUS SCOPES WOULD HAVE BEEN RECOGNIZED BY THE ETD AND WOULD HAVE GENERATED ERROR MESSAGE 3207 WHEN WASHED ON THE LEVEL WITH THE BROKEN PULL ROD. ADDITIONAL SCOPES, SUCH AS FUJI SCOPES WOULD NOT HAVE BEEN REGISTERED IN THE MACHINE AND DID NOT HAVE RFID TAGS, WHICH WOULD HAVE CAUSED THE SCOPES TO BE RECOGNIZED AS UNKNOWN SCOPES. TO DATE, SERIAL NUMBERS OF THE AFFECTED ENDOSCOPES HAVE NOT BEEN PROVIDED AND NO ENDOSCOPES HAVE BEEN RETURNED TO OLYMPUS FOR EVALUATION. AS SUCH, A DEVICE HISTORY RECORD REVIEW (DHR) AND DEVICE EVALUATION WERE BOTH UNABLE TO BE PERFORMED. THE EXACT ROOT CAUSE OF THE EVENT COULD NOT BE IDENTIFIED. HOWEVER, THE INVESTIGATION DETERMINED IT WAS LIKELY CAUSED BY THE FACILITY STAFF BEING LESS TRAINED ON DEVICE HANDLING AND/OR REPROCESSING IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THE IFU (REPROCESSING MANUAL) CAUTIONS AGAINST INSUFFICIENT REPROCESSING IN THE PRECAUTIONS SECTION AS BELOW: ¿AN INSUFFICIENTLY REPROCESSED ENDOSCOPE AND/OR ACCESSORY MAY POSE AN INFECTION CONTROL RISK TO THE PATIENTS AND/OR OPERATORS WHO TOUCH THEM.¿ TO PREVENT INCORRECT POSITIONING OF ENDOSCOPES, A DETAILED DESCRIPTION OF THE POSITIONING PROCEDURE IS GIVEN IN THE INSTRUCTIONS FOR USE. TO EMPHASIZE POTENTIAL RISKS IN THIS CONTEXT, THE FOLLOWING WARNING IS HIGHLIGHTED IN THE IFU ¿WARNING. RISK OF INJURY TO THE PATIENT. IF THE ENDOSCOPE OR THE VALVES ARE INSERTED INCORRECTLY INTO THE BASKET, THIS CAN CAUSE INEFFICIENT REPROCESSING AND INFECTION OF THE PATIENT. ¿ CORRECTLY INSERT THE ENDOSCOPE AND THE VALVES INTO THE BASKET. ¿ CHECK THAT THE ENDOSCOPE AND THE VALVES CORRECTLY FIT INTO THE HOLDERS IN THE BASKET.¿ FURTHERMORE, THE IFU STATES THE FOLLOWING REGARDING THE RIFD TAGS: ¿THE IDENTIFICATION OF ENDOSCOPES IS BASED ON RFID TECHNOLOGY. FOR THIS REASON, THE ENDOSCOPES MUST BE EQUIPPED WITH AN RFID TAG. ENDOSCOPES WITHOUT AN RFID TAG ARE HANDLED AS UNKNOWN ENDOSCOPES.¿ IN THE CASE THAT THE ENDOSCOPES ARE REPROCESSED AS AN UNKNOWN SCOPE, THE IFU PROVIDES AN ADDITIONAL WARNING: ¿WARNING. RISK OF INJURY TO THE PATIENT. WHEN AN ENDOSCOPE IS REPROCESSED USING THE ADAPTER CONFIGURATION ¿UNKNOWN SCOPE,¿ THE WASHER-DISINFECTOR DOES NOT CHECK WHETHER ALL ADAPTERS ARE CONNECTED CORRECTLY. THIS CAN LEAD TO INFECTION OF THE PATIENT. ¿ CONTACT AN ADVANCED USER TO ASSIGN THE CORRECT ENDOSCOPE TYPE TO THE ENDOSCOPE ACCORDING TO THE LIST ETD DOUBLE ¿ COMPATIBLE HOLDERS, ADAPTERS, EXPANSION KITS AND RFID TAGS FOR OLYMPUS ENDOSCOPES. ¿WHEN THE REPROCESSING REPORT LISTS THE ADAPTER CONFIGURATION AS ¿UNKNOWN SCOPE¿, VISUALLY CHECK WHETHER ALL ADAPTERS CONTROL ARE STILL CONNECTED CORRECTLY TO THE ENDOSCOPE AFTER THE REPROCESSING PROCESS HAS BEEN COMPLETED.¿ INVESTIGATION ACTIVITIES HAVE BEEN OPENED TO MANAGE THE ACTIONS RELATED TO THIS ISSUE AND ANY REQUIRED MDR REPORTING. THIS REPORT WILL BE SUPPLEMENTED IF ADDITIONAL INFORMATION IS OBTAINED AT A LATER DATE. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, ENDOSCOPES WERE REPROCESSED IN AN OLYMPUS ETD (ENDOTHERMO DISINFECTOR) DOUBLE WHEN THE ETD WAS BROKEN. THE ETD HAD A BROKEN PULL ROD AND THE MACHINE WOULD NOT ALARM WHEN THE USER WAS CLEANING THE ENDOSCOPES. IT IS UNKNOWN HOW MANY SCOPES WERE REPROCESSED IN THE ETD WHEN IT WAS NOT WORKING. THE SCOPES HAD ALREADY BEEN USED WHEN THE ETD WAS IDENTIFIED AS NOT WORKING. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION OF SCOPES BEING REPROCESSED IN A MALFUNCTIONING ETD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129945 EVIS EXERA LLL COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. CF-HQ190L 04953170305115

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ETD (ENDOTHERMO DISINFECTOR) DOUBLE