BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OES CYSTONEPHROFIBERSCOPE

    MDR report key: 11453621 · Received March 10, 2021

    Report

    Report Number
    8010047-2021-03529
    Event Type
    Malfunction
    Date Received
    March 10, 2021
    Date of Event
    February 12, 2021
    Report Date
    April 19, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FAJ
    UDI-DI
    04953170339417
    PMA / PMN Number
    K032092
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE LEGAL MANUFACTURER INVESTIGATION AND DEVICE EVALUATION. THE LEGAL MANUFACTURER (LM) REVIEWED THE CONTENT OF THIS COMPLAINT FOR FURTHER INVESTIGATION. THE LEGAL MANUFACTURER WAS UNABLE TO DETERMINE THE ROOT CAUSE. THE LM REPORTED THAT THE MOST PROBABLE CAUSE FOR THE REPORTED EVENT IS AS FOLLOWS: THIS PRODUCT'S INSTRUCTION MANUAL CONTAINS INFORMATION ON REPROCESS PROCEDURES, AND THE LEGAL MANUFACTURER BELIEVES THAT COMPLYING WITH THESE INSTRUCTIONS WILL PREVENT THE OCCURRENCE OF THIS EVENT. THEREFORE, WE ASSUME THAT THIS EVENT WAS CAUSED BY THE USER. CONFIRMATION OF THE CONTENT OF THE INSTRUCTION MANUAL WAS PERFORMED BY THE LEGAL MANUFACTURER CONCERNING THE CYF-5, REPROCESS PROCEDURE WAS DESCRIBED IN THE FOLLOWING ITEMS. BY OBSERVING THIS, IT IS JUDGED THAT THE EVENT POINTED OUT CAN BE PREVENTED. ¦CHAPTER 6 RECOMMENDED REPROCESSING METHODS AND CHEMICAL AGENTS(P.45) ¦CHAPTER 7 CLEANING, DISINFECTION AND STERILIZATION PROCEDURES FOR ENDOSCOPIC INSTRUMENTS(P.59) AS THE RESULTS OF THE DHR REVIEW, IT WAS CONFIRMED THAT THERE WAS NO ABNORMALITY IN MANUFACTURING, CONCESSION, AND VARIATION. IT WAS CONFIRMED THAT THERE WAS NO UNEVENNESS.

    Additional Manufacturer Narrative · 1

    AS PART OF INVESTIGATION, ON FEBRUARY 23, 2021, AN ESS WAS DISPATCHED TO THE USER FACILITY TO OBSERVE THE FACILITY¿S REPROCESSING PRACTICES AND PROVIDE AN IN-SERVICE. THE ESS REPORTED THAT THE IN-SERVICE WAS PROVIDED TO REVIEW THE REPROCESSING OF THE FACILITY¿S GI ENDOSCOPES. THE IN-SERVICE CONSISTED OF REPROCESSING TRAINING WHICH INCLUDED PROPER ENDOSCOPE HANDLING, REPAIR PREVENTION, PRE-CLEANING, LEAK TESTING, MANUAL CLEANING AND HIGH LEVEL DISINFECTION ACCORDING TO THE OLYMPUS REPROCESSING MANUAL. DURING TRAINING A MANAGER FROM THE USER FACILITY TIMED THE PROCESS STARTING FROM THE PRE-CLEANING UNTIL IN THE HLD. THE ESS WAS INFORMED BY THE FACILITY¿S MANAGER THAT THE STAFF DOES NOT PERFORM ANY PRE CLEANING OR HANGING OF THE SCOPES. THE ESS OBSERVED THAT THE SCOPES ARE SET IN A DISTILLED WATER BASIN AFTER THE HIGH LEVEL DISINFECTANT AND RINSE. THE SCOPE SITS WITH THE TIP SUBMERGED IN THE DISTILLED WATER FOR UP TO AN HOUR BEFORE IT IS USED AGAIN. THE ESS REPORTED THAT IT WAS UNCLEAR HOW OFTEN THAT WATER WAS CHANGED. THE ESS REPORTED THAT THE REPROCESSING ISSUES WERE DISCUSSED WITH THE FACILITY¿S MANAGER. THE MANAGER INFORMED THE ESS THAT THE PROBLEMS WITH THE CLEANING AND REPROCESSING OF THE SCOPES (THE NEED FOR PRE CLEAN, LEAK TESTING EVERY SCOPE EVERY USE AS WELL AS HANGING ) WILL BE DISCUSSED WITH THE DOCTOR. THE SCOPE WILL NOT BE RETURNED TO THE SERVICE CENTER FOR EVALUATION. THE INSTRUCTION MANUAL PROVIDE THE FOLLOWING WARNING ABOUT IMPROPER REPROCESS. ¿REPROCESSING AND STORAGE THESE INSTRUMENTS WERE NOT DISINFECTED OR STERILIZED BEFORE SHIPMENT. BEFORE USING THESE INSTRUMENTS FOR THE FIRST TIME, REPROCESS THEM ACCORDING TO THE INSTRUCTIONS IN CHAPTER 5, ¿REPROCESSING: GENERAL POLICY¿ THROUGH CHAPTER 7, ¿CLEANING, DISINFECTION AND STERILIZATION PROCEDURES¿. AFTER USING THE INSTRUMENT, REPROCESS AND STORE IT ACCORDING TO THE INSTRUCTIONS IN CHAPTERS 5, THROUGH CHAPTER 9. IMPROPER AND/OR INCOMPLETE REPROCESSING OR STORAGE CAN PRESENT AN INFECTION CONTROL RISK, CAUSE EQUIPMENT DAMAGE OR REDUCE PERFORMANCE.¿ THE INVESTIGATION IS ONGOING; THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 1

    THE SERVICE CENTER WAS INFORMED THAT DURING A REPAIR REDUCTION TELECONFERENCE WITH THE USER FACILITY AND ENDOSCOPY SUPPORT SPECIALIST (ESS) IT WAS DETERMINED THAT AN INCORRECT OR IMPROPERLY REPROCESSED SCOPE WAS USED. THE CUSTOMER REPORTED LEAK TESTING HAS NOT BEEN A PERFORMED FOR TWENTY YEARS DUE TO THE FACILITY¿S TIME RESTRICTIONS AND STAFF ISSUES. THE SCOPE IS NOT RINSED 3X AS THIS WILL DELAY THE NUMBER OF PATIENTS THE FACILITY CAN SERVICE. THE FACILITY DOES NOT HAVE THE APPROPRIATE SET UP FOR THE PROPER REPROCESSING AS STATED IN OLYMPUS INSTRUCTIONS FOR USE (IFU). THE ESS RE EDUCATED CUSTOMER ON THE POTENTIAL RISKS ASSOCIATED WITH IMPROPER REPROCESSING. NO ADVERSE PATIENT OUTCOMES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350169 OES CYSTONEPHROFIBERSCOPE CYSTONEPHROFIBERSCOPE FAJ OLYMPUS MEDICAL SYSTEMS CORP. CYF-5 04953170339417

    Patients

    Seq Age Sex Outcome Treatment
    1