BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

    MDR report key: 6627555 · Received June 8, 2017

    Report

    Report Number
    2951238-2017-00399
    Event Type
    Malfunction
    Date Received
    June 8, 2017
    Report Date
    March 1, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    ODG
    PMA / PMN Number
    PK093395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION, AN UPDATE ON THE OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) ON-SITE VISIT. THE ESS VISITED THE USER FACILITY ON JULY 5, 2017. THE USER FACILITY INDICATED THAT THEIR SCOPE CULTURE IS STILL TESTING POSITIVE FOR KLEBSIELLA PNEUMONIA AND ENTEROCOCCUS FAECALIS. THE CULTURE IS NEGATIVE FROM THE DISTAL END SWABS BUT POSITIVE FROM THE INSTRUMENT CHANNEL STERILE WATER FLUSH. THE USER FACILITY IS CURRENTLY WEIGHING OUT OPTIONS TO ADDRESS THE SITUATION AND WHETHER THE SCOPE WILL BE RETURNED TO OLYMPUS FOR ADDITIONAL EVALUATION. THE USE FACILITY HAS DECLINED A REPROCESSING IN-SERVICE TRAINING AT THIS POINT.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE INDEPENDENT LABORATORY RESULTS. THE SCOPE WAS SENT TO AN INDEPENDENT LABORATORY FOR MICROBIAL TESTING. THE RESULTS OF THE LABORATORY TESTING CONFIRMED THE USER FACILITY¿S REPORT OF POSITIVE CULTURE. THE SCOPE TESTED POSITIVE FOR KLEBSIELLA PNEUMONIA AND STAPHYLOCOCCUS HOMINIS. THE SCOPE WAS ETHYLENE OXIDE (ETO) STERILIZED AND RETURNED TO THE USER FACILITY.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO MAKE A CORRECTION ON THE PROCODE FROM ITX TO ODG.

    Additional Manufacturer Narrative · 1

    THE SCOPE WAS RETURNED TO OLYMPUS FOR EVALUATION. A VISUAL INSPECTION OF THE SCOPE WAS PERFORMED AND WAS UNABLE TO FIND ANY SIGNS OF FOREIGN MATERIAL/SUBSTANCE/STAIN INSIDE THE BIOPSY CHANNEL, BIOPSY PORT, SUCTION CHANNEL, SUCTION PORT, AIR/WATER PORT, AND NOZZLE WHEN INSPECTED WITH AN OLYMPUS BOROSCOPE AND TELESCOPE. ADDITIONALLY, THERE WERE NO SIGNS OF FOREIGN SUBSTANCE/MATERIALS FOUND ON THE INSERTION TUBE, BENDING SECTION COVER, BENDING SECTION COVER GLUE, ELEVATOR FORCEPS RAISER, DISTAL END COVER, LIGHT GUIDE LENS/GLUE, AND OBJECTIVE LENS/GLUE; HOWEVER, THE BENDING SECTION COVER GLUE FROM THE DISTAL END SIDE AND INSERTION TUBE SIDE WERE FOUND CRACKED. THERE WAS ALSO EVIDENCE OF DISCOLORATION ON BOTH ENDS OF THE BENDING SECTION COVER GLUE THAT MOST LIKELY CAUSED THE GLUE TO CRACK. THE SCOPE WAS SERVICED AND RETURNED TO THE USER FACILITY. AS PART OF OUR INVESTIGATION, AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) WAS REQUESTED TO BE DISPATCHED TO THE USER FACILITY TO OBSERVE THE FACILITIES REPROCESSING PRACTICE AND PROVIDE REPROCESSING TRAINING. TO DATE, THE ESS VISIT HAS NOT BEEN FINALIZED. THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED AS THERE WERE NO SIGNS OF FOREIGN MATERIAL FOUND ON THE SCOPE; HOWEVER, DUE TO THE CONDITION OF THE BENDING SECTION RUBBER GLUE, IMPROPER MAINTENANCE OF THE SCOPE COULD NOT BE RULED OUT AS A CONTRIBUTORY FACTOR TO THE REPORTED EVENT. THE INSTRUCTION MANUAL FOR USE PROVIDES SEVERAL WARNING AND CAUTION STATEMENTS IN AN EFFORT TO PREVENT EQUIPMENT DAMAGE AND PATIENT/USER HARM. "THE PROBABILITY OF FAILURE OF THE ENDOSCOPE AND ANCILLARY EQUIPMENT INCREASES AS THE NUMBER OF PROCEDURES PERFORMED AND/OR THE TOTAL OPERATING HOURS INCREASE. IN ADDITION TO THE INSPECTION BEFORE EACH PROCEDURE, THE PERSON IN CHARGE OF MEDICAL EQUIPMENT MAINTENANCE IN EACH HOSPITAL SHOULD INSPECT THE ITEMS SPECIFIED IN THIS MANUAL PERIODICALLY. AN ENDOSCOPE WITH AN OBSERVED IRREGULARITY SHOULD NOT BE USED, BUT SHOULD BE INSPECTED. IF THE IRREGULARITY IS STILL OBSERVED AFTER INSPECTION, FOLLOW THE INSTRUCTIONS GIVEN IN CHAPTER 10, TROUBLESHOOTING. USING AN INSTRUMENT THAT IS NOT FUNCTIONING PROPERLY MAY COMPROMISE PATIENT OR OPERATOR SAFETY AND MAY RESULT IN MORE SEVERE EQUIPMENT DAMAGE."

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT AFTER REPROCESSING THE SCOPE, THE SCOPE CULTURE TESTED POSITIVE FOR KLEBSIELLA PNEUMONIA AND ENTEROCOCCUS FAECALIS. THERE WAS NO PATIENT INVOLVEMENT WITH THE SCOPE. IN ADDITION, IT WAS FURTHER REPORTED THAT THE SCOPE IS REPROCESSING USING A NON OLYMPUS MEDIVATORS AUTOMATED ENDOSCOPE REPROCESSOR (AER) MACHINE. THERE ARE REPORTED PROBLEMS WITH THE AER MACHINE. THE LAST PREVENTATIVE MAINTENANCE (PM) FOR THE AER MACHINE WAS ON MAY 2017. PRE-CLEANING IS PERFORMED IMMEDIATELY FOLLOWING OLYMPUS GUIDELINES. SCOPE CHANNELS ARE CLEANED USING AN OLYMPUS SINGLE USE BRUSH. SCOPE IS LEAK TESTED USING AN OLYMPUS LEAK TESTER PRIOR TO MANUAL CLEANING. SCOPE IS STORED IN A VERTICAL HANGING CABINET. THE LAST ENDOSCOPY SUPPORT SPECIALIST (ESS) REPROCESSING IN-SERVICE VISIT WAS ON OCTOBER 2016. NO CHANGES TO THE USER FACILITIES REPROCESSING STAFF SINCE THE LAST ESS IN-SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408240 EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG OLYMPUS MEDICAL SYSTEMS CORP. GF-UCT180 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1