BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASONIC GASTROVIDEOSCOPE

    MDR report key: 14728509 · Received June 17, 2022

    Report

    Report Number
    8010047-2022-10229
    Event Type
    Malfunction
    Date Received
    June 17, 2022
    Date of Event
    May 17, 2022
    Report Date
    November 2, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    ODG
    UDI-DI
    04953170356261
    PMA / PMN Number
    K051541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER PROVIDED THE HMI (HYGIENE MICROBIOLOGICAL INVESTIGATION) RESULTS. THE CUSTOMER HMI (HYGIENE MICROBIOLOGICAL INVESTIGATION) RESULTS REPORTED THE DEVICE TESTED TWICE (SAMPLE TIME OF TESTING: 14:44, 14:45 HOURS) AND THE DEVICE TESTED POSITIVE WITH THE FOLLOWING MICROORGANISM: ESCHERICHIA COLI GREATER THAN 100 KBE(CFU/ML). OLYMPUS SUBSIDIARY FOR HMI (HYGIENE MICROBIOLOGICAL INVESTIGATION) INVESTIGATION RESULTS HAS NOT YET BEEN RECEIVED AND NOT AVAILABLE AT THIS TIME. BELOW ARE INFORMATION ON CUSTOMERS CDS CHECKLIST: PRE CLEANING TAKES PLACE AFTER THE PROCEDURE ( BETWEEN 5 TO 30 MINUTES CLEANING). ALL CHANNELS OF THE ENDOSCOPE CONNECTED TO AER SCOPES REPROCESSOR INJECTION PORTS AND SUPPLIED WITH DISINFECTANT. (DISINFECTANT NAME NOT PROVIDED). AER SCOPES REPROCESSOR DISINFECTION PROCESS ARE ACCORDING TO AER MANUFACTURERS RECOMMENDATION. SUPPLEMENTAL REPORT(S) WILL BE SUBMITTED SHOULD ANY RELEVANT NEW INFORMATION IS AVAILABLE. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON RESULTS OF THIRD PARTY TESTING, THE DEVICE EVALUATION, AND THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE WAS EVALUATED WHERE NO ABNORMALITIES WERE FOUND THAT COULD HAVE LED TO THE POSITIVE CULTURE. SEVERAL DEFECTS WERE NOTED WHERE THE SCOPE CONNECTOR COVER PLATE IS DETACHED, CORROSION ON THE SCOPE CYLINDER, PAINT PEELING ON AIR/WATER CYLINDER, SWITCH BOX IS DEFORMED, THE SHEET HOLDER UNIT HAS CORROSION DUE TO WATER LEAKAGE, ACOUSTIC LENS IS DAMAGED, OBJECT LENS IS SCRATCHED, THE ADHESIVE ON THE BENDING SECTION COVER IS CHIPPED, AND THE CHANNEL TUBE IS WORN. HOWEVER, THESE DEFECTS ALONE ARE NOT CONSIDERED SEVERE ENOUGH TO CAUSE A POTENTIAL ADVERSE EVENT. 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 ROOT CAUSE COULD NOT BE DETERMINED. GROWTH OF MICROORGANISMS WERE FOUND THROUGH CULTURE TESTING BY THE USER AFTER REPROCESSING. HOWEVER, WHEN OLYMPUS CULTURE TESTED AFTER REPROCESSING IN ACCORDANCE WITH INSTRUCTIONS FOR USE (IFU) BEFORE REPAIR, THE RESULTS CONFORMED TO THE REGULATION'S RECOMMENDATION. THE FOLLOWING IS INCLUDED IN THE DEVICE INSTRUCTIONS FOR USE: ¿CHAPTER 6 COMPATIBLE REPROCESSING METHODS AND CHEMICAL AGENTS CHAPTER 7 CLEANING, DISINFECTION, AND STERILIZATION PROCEDURES¿ OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT THE DEVICE FAILED THE HYGIENE TEST TWICE. ISSUE OCCURRED DURING REPROCESSING. IT WAS STATED THAT SUCTION CHANNEL PERHAPS DEFECTIVE. THERE WAS NO PATIENT HARM REPORTED. NO USER INJURY REPORTED . LOANER DEVICE WAS SENT TO CUSTOMER FOR IMMEDIATE CUSTOMER SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1261700 ULTRASONIC GASTROVIDEOSCOPE ULTRASONIC GASTROVIDEOSCOPE ODG OLYMPUS MEDICAL SYSTEMS CORP. GF-UE160-AL5 04953170356261

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown