BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 12760893 · Received November 7, 2021

    Report

    Report Number
    8010047-2021-14166
    Event Type
    Malfunction
    Date Received
    November 7, 2021
    Date of Event
    October 14, 2021
    Report Date
    December 20, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS PART OF INVESTIGATION, WHILE ONSITE THE ESS EDUCATED THE STAFF ON PROPER LEAKAGE TESTING TECHNIQUES. THE ESS NOTED A LEAK ON THE BENDING SECTION OF THE GASTROSCOPE PROVIDED FOR TRAINING. THE ESS PROVIDED THE CUSTOMER WITH INSTRUCTIONS TO REPROCESS DAMAGED SCOPES WERE PROVIDED TO CUSTOMER. THE ESS COMPLETED A REPROCESSING IN-SERVICE FOR GI TECHNICIANS. THE ESS NOTED SOME DEVIATIONS FROM THE OLYMPUS REPROCESSING DURING THE IN-SERVICE. A FOLLOW-UP IN-SERVICE WAS SCHEDULED TO REVIEW PROPER REPROCESSING INSTRUCTIONS WITH ALL STAFF IN CHARGE OF REPROCESSING. THE GI MANAGER INFORMED THE ESS THAT THE FACILITY RECENTLY PURCHASED A SCOPE BUDDY PLUS FLUSHING MACHINE WHICH WILL BE INSTALLED IN APPROXIMATELY ONE WEEK TO START FLUSHING ENDOSCOPE CHANNELS. THE SCOPE WAS NOT RETURNED TO SERVICE CENTER FOR EVALUATION. AN INVESTIGATION IS ONGOING TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. IF ADDITIONAL INFORMATION IS RECEIVED THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. HOWEVER, IT IS CONSIDERED PROBABLE THAT THE FACILITY STAFF WAS NOT TRAINED ON DEVICE HANDLING AND/OR REPROCESSING ACCORDING TO THE INSTRUCTIONS FOR USE. THE INSTRUCTIONS FOR USE CAUTIONS THE USER AGAINST INSUFFICIENT REPROCESSING, AS FOLLOWS: "1.4 PRECAUTIONS: AN INSUFFICIENTLY CLEANED, DISINFECTED OR STERILIZED ENDOSCOPE AND/OR ACCESSORIES MAY POSE AN INFECTION CONTROL RISK TO THE PATIENTS AND/OR OPERATORS WHO CONTACT THEM." CORRECT STEPS ARE SPECIFIED IN "5.4 LEAKAGE TESTING OF THE ENDOSCOPE". ADDITIONAL CORRECT STEPS ARE SPECIFIED IN "5.5 MANUALLY CLEANING THE ENDOSCOPE AND ACCESSORIES¿. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE ENDOSCOPY SUPPORT SPECIALIST (ESS) REPORTED THAT DURING AN ONSITE REPROCESSING OBSERVATION VISIT AT THE CUSTOMER¿S SITE, IT WAS NOTED THAT THE SCOPE WAS BEING IMPROPERLY REPROCESSED. THE AIR/WATER CHANNEL & AUXILIARY WATER CHANNEL WERE NOT BEING FLUSHED DURING PRE-CLEANING ON ANY OF THE GASTROINTESTINAL SCOPES. THE ESS REPORTED THAT THE FACILITY¿S GI MANAGER MENTIONED THE STAFF WAS NOT PERFORMING LEAK TEST, ASPIRATING DETERGENT WITH A SUCTION TUBE, NOR FLUSHING ENDOSCOPE CHANNELS DURING MANUAL CLEANING. THE STAFF WAS ONLY WIPING DOWN SCOPES AND BRUSHING CHANNELS BEFORE PLACING THEM ON THE MEDIVATORS ADVANTAGE PLUS AUTOMATIC ENDOSCOPE REPROCESSOR (AER). NO ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1662131 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-H190

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown SUCTION TUBE MH-856