BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSF-3 (OAI)

    MDR report key: 9513205 · Received December 23, 2019

    Report

    Report Number
    8010047-2019-04542
    Event Type
    Malfunction
    Date Received
    December 23, 2019
    Date of Event
    November 26, 2019
    Report Date
    January 27, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FAM
    PMA / PMN Number
    K954451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. AS STATED, THE ESS WILL PERFORM A SITE VISIT ONCE THE FACILITY ARE READY TO CONTINUE TO DO SCOPES IN THE USER FACILITY, AND REVIEW THE SET UP, AND IN-SERVICE THE STAFF BEFORE THEY GO LIVE WITH PATIENTS AGAIN. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY ONCE NEW INFORMATION BECOMES AVAILABLE. AS A PREVENTIVE MEASURE AND AS STATED IN THE USERS MANUAL: THIS INSTRUMENT WAS NOT DISINFECTED OR STERILIZED BEFORE SHIPMENT. BEFORE USING THIS INSTRUMENT FOR THE FIRST TIME, REPROCESS IT ACCORDING TO THE REPROCESSING MANUAL¿. AFTER USING THIS INSTRUMENT, REPROCESS AND STORE IT ACCORDING TO THE INSTRUCTIONS IN THE ENDOSCOPE¿S COMPANION MANUAL, THE ¿OLYMPUS OSF-3 ENDOSCOPE REPROCESSING MANUAL¿. IMPROPER AND/OR INCOMPLETE REPROCESSING OR STORAGE CAN PRESENT AN INFECTION CONTROL RISK, CAUSE EQUIPMENT DAMAGE OR REDUCE PERFORMANCE.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORTS HAS UPDATES ON THE FOLLOWING : ENDOSCOPY SUPPORT SPECIALIST (ESS) REPORTED THAT THE CUSTOMER FACILITY IS BACK UP AND RUNNING. THE FACILITY WORKED CLOSELY WITH THE ESS, INFECTION CONTROL AND THE SALES REPRESENTATIVE TO OBTAIN EVERYTHING THE FACILITY NEEDED FOR THE SCOPE REPROCESSING. IN ADDITION, THE ESS VISITED THE FACILITY AND OBSERVED THE SITES SCOPE REPROCESSING SYSTEM AND PERFORMED TRAINING. TO DATE, THE FACILITY IS OPERATIONAL WITH NO ISSUE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FACILITY DOCTOR AND THE HEAD OF INFECTION CONTROL REQUESTED A ESS (ENDOSCOPE SPECIALIST) TO REVIEW THE SITE SCOPES REPROCESSING PROCEDURE. THERE ARE A TOTAL OF TWO (2) SCOPES IN THE FACILITIES AS REPORTED BY THE ESS. UPON INSPECTION AND REVIEW, IT WAS FOUND OUT THAT THE FACILITY ARE NOT COMPLIANT WITH OLYMPUS AND THEIR SCOPES REPROCESSING STEPS. THE FACILITY DOES NOT HAVE AN AW CHANNEL CLEANING ADAPTOR FOR PRE-CLEANING, NO LEAK TESTER TO BE USED BEFORE MANUAL REPROCESSING STARTS, NO SUCTION OR SUCTION TUBING, NO INJECTION TUBING FOR FLUSHING CHANNELS, NOT USING A 30CC SYRINGE, NO WATER RINSE OR ALCOHOL RINSE BINS AFTER THE CIDEX CONTACT TIME. THE ESS DISCUSSED THE ISSUES TO THE DOCTOR AND THE HEAD OF INFECTION CONTROL THAT IMMEDIATE STEPS NEEDS TO BE TAKEN FOR THE FACILITIES TO BE COMPLIANT. THE FACILITY IN RESPONSE TO THE OBSERVATION ORDERED THE NECESSARY EQUIPMENT AND DEVICES FOR SCOPE PROCESSING AND WHILE WAITING FOR THE ITEMS TO BE AVAILABLE, THE ESS RECOMMENDED THE FACILITY TO HAVE THE G.I LABORATORY TO CLEAN THE FACILITY SCOPES. IN ADDITION, THE SITES INFECTION CONTROL WILL BE SHUTTING DOWN THE SCOPE REPROCESSING IN THE FACILITY UNTIL THEY CORRECT THE REPROCESSING STEPS TO BE COMPLIANT. ESS WILL PERFORM A SITE VISIT ONCE THE FACILITY ARE READY TO CONTINUE TO DO SCOPES IN THEIR FACILITY, AND REVIEW THE SET UP, AND IN-SERVICE THE STAFF BEFORE THEY GO LIVE WITH PATIENTS AGAIN. TO DATE, THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. 1 OF 2

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1308914 OSF-3 (OAI) SIGMOIDOFIBERSCOPE FAM OLYMPUS MEDICAL SYSTEMS CORP. OSF-3

    Patients

    Seq Age Sex Outcome Treatment
    1