BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS EVIS EXERA II GASTROVIDEOSCOPE

    MDR report key: 2576194 · Received May 4, 2012

    Report

    Report Number
    8010047-2012-00139
    Event Type
    Malfunction
    Date Received
    May 4, 2012
    Report Date
    April 6, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GCK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY VIA TELEPHONE AND IN WRITING TO OBTAIN MORE INFO REGARDING THE REPORT, BUT NO FURTHER INFO PROVIDED. IT IS UNK WHICH OF THE TWO SERIAL NUMBERS OF GASTROSCOPES WAS USED ON THE PT. THE CURRENT CONDITION OF THE PT IS UNK. THE FLUID SAMPLE AND GAUZE WERE FORWARDED TO AN OLYMPUS OFF-SITE LAB FOR TESTING. THE TEST RESULTS FROM BOTH THE LIQUID SAMPLE AND THE GAUZE SAMPLE INDICATED THAT THERE WAS BLOOD IN THE SAMPLE. BASED ON THE GLUTARALDEHYDE RESIDUAL ANALYSIS PERFORMED, THE SAMPLE SHOWED RESIDUAL GLUTARALDEHYDE ON THE GAUZE SAMPLE, BUT THE LIQUID SAMPLE DID NOT SHOW ANY GLUTARALDEHYDE RESIDUALS. AN OLYMPUS FIELD SERVICE ENGINEER VISITED THE USER FACILITY TO EVALUATE THE OER-PRO AND FOUND THAT ONE OF THE YELLOW PORT CONNECTORS HAD BEEN REMOVED FROM THE UNIT BY THE CUSTOMER. THE FSE REINSTALLED THE PORT CONNECTOR AND TESTED THE UNIT WITH THE TEST JIG ATTACHED TO THE YELLOW CONNECTOR PORT, BUT NO WATER WAS NOTED TO BE COMING OUT OF THE SPRAY HOLE OF THE YELLOW CONNECTOR. THE CONNECTOR APPEARS TO HAVE BEEN CLOGGED WITH HARD WATER DEPOSITS, WHICH LIKELY CAUSED THE AUXILIARY WATER CHANNEL OF THE GASTROSCOPES TO BE IMPROPERLY REPROCESSED. THE YELLOW CONNECTOR WAS REPLACED, AND THE UNIT WORK APPROPRIATELY. THE FSE PROVIDED THE USER FACILITY STAFF INFO ON THE FUNCTION OF THE OER-PRO INCLUDING OPERATIONAL MANUALS. THE FSE CONVERTED THE AFFECTED UNIT TO USE SOFT WATER AND ACECIDE DISINFECTANT TO CLEAR THE ISSUE OF HARD WATER DEPOSITS. THIS IS THE FIRST OF THREE REPORTS. CROSS REFERENCE MFR REPORT #8010047-2012-00138 AND 8010047-2012-00140.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT TWO GASTROSCOPES WERE LEAKING PINK FLUID FROM THE AUXILIARY WATER PORTS AFTER HAVING REPROCESSED IN THE OER-PRO. ONE OF THE TWO GASTROSCOPES WAS USED ON A PT. THE USER FACILITY STAFF REPORTED THAT PRIOR TO STARTING THE PROCEDURE, THE LIGHT IN THE ROOM WAS DEACTIVATED. THE USERS REPORTEDLY FLUSHED WATER IN THE AUXILIARY WATER CHANNEL AND FLUID WAS DRAINED IN A PIECE OF GAUZE AND THE USERS PROCEEDED WITH THE PROCEDURE. THE PROCEDURE WAS SAID TO HAVE BEEN COMPLETED WITH NO ISSUE NOTED, BUT UPON REACTIVATING THE LIGHT IN THE PROCEDURE ROOM, THE USERS REPORTEDLY OBSERVED PINK FLUID ON THE GAUZE. THE PT WAS SAID TO HAVE BEEN EXPOSED TO AN UNK PINK FLUID AND THE USERS ALLEGED THAT THE GASTROSCOPES MAY NOT HAVE BEEN REPROCESSED PROPERLY. THE USERS COLLECTED SAMPLE OF THE PINK FLUID FROM BOTH OF THE GASTROSCOPES AND REQUESTED OLYMPUS TO CONDUCT FURTHER TESTING OF THE FLUID SPECIFICALLY TO TEST FOR PRESENCE OF BLOOD AND ALDAHOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA II GASTROVIDEOSCOPE GASTROVIDEOSCOPE GCK OLYMPUS MEDICAL SYSTEMS CORPORATION GIF-H180J NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK OLYMPUS OER-PRO REPROCESSOR WITH SERIAL#(B)(4)| GIF-H180J WITH SERIAL #(B)(4)