BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 13581134 · Received February 22, 2022

    Report

    Report Number
    8010047-2022-03376
    Event Type
    Malfunction
    Date Received
    February 22, 2022
    Date of Event
    January 5, 2022
    Report Date
    December 13, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    UDI-DI
    04953170343360
    PMA / PMN Number
    K112680
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RECEIVED AND EVALUATED. SERVICE REPAIR UPON INSPECTION NOTED THE FOLLOWING DEVICE EVALUATION FINDINGS: DEFECT WAS FOUND DURING REPAIR. THE DEVICE CHANNEL WAS REPORTEDLY WITH ISSUES ON THE AW (AIRWATER) CHANNEL DURING INCOMING INSPECTION. AT REPAIR, THE TECHNICIANS NOTICED FOREIGN MATERIALS LODGED AT THE INSIDE OF THE CHANNEL. FURTHERMORE, THE FOLLOWINGS DEFECTS WERE NOTED ON THE DEVICE: FORCEPS CHANNEL PORT IS DEFORMED, GRIP HAS SCRATCHED, THE S-CYLINDER HAS DISCOLORATION. SWITCH BOX HAS DENT, SWITCH #1 HAS SCRATCH. UP/DOWN KNOB, LG (LIGHT GUIDE) LENS, SC-CASE, S-COVER, IMAGE GUIDE CONNECTOR (IG), C-COVER WERE FOUND WITH SCRATCHES AND LG LENS WERE CRACKED. DUE TO DAMAGE ON A/W TUBE, NO WATER AND AIR FED DUE TO WEAR OF ANGLE WIRE, THE PLAY OF U/D AND R/L KNOBS ARE OUT OF STANDARD. BENDING TUBE IS DEFORMED , CONNECTING TUBE WITH SCRATCH AND UNIVERSAL CORD HAS COATING PEELING. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    CORRECTION TO G3 OF THE INITIAL MEDWATCH. THE AWARE DATE SHOULD BE 11-JAN-2022. INVESTIGATION ACTIVITIES HAVE BEEN OPENED TO MANAGE THE ACTIONS RELATED TO THIS REPORT AND ANY REQUIRED MDR REPORTING.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: H4, H6 AND H10. THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE INVESTIGATION CONFIRMED THE BROWNISH-RED MATERIAL THAT WAS FOUND IN THE AIR/WATER NOZZLE. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS PROBLEM. A DEFINITIVE ROOT CAUSE FOR THIS ISSUE WAS NOT ESTABLISHED. HOWEVER, IT WAS THOUGHT THAT THE ISSUE OCCURRED BECAUSE THE REPROCESSING METHOD AT FACILITY DIFFERED FROM THAT SPECIFIED IN THE DEVICE¿S INSTRUCTIONS FOR USE (IFU). THE OCCURRENCE OF THE REPORTED PROBLEM CAN BE PREVENTED BY ADHERING TO THE INSTRUCTIONS FOR USE (IFU), WHICH STATE THE FOLLOWING: ¿INSUFFICIENT CLEANING AND DISINFECTION OR STERILIZATION OF THE ENDOSCOPE MAY POSE AN INFECTION-CONTROL RISK TO THE PATIENT AND/OR OPERATORS PERFORMING THE NEXT PROCEDURE WITH THE ENDOSCOPE. IF THE ENDOSCOPE IS NOT IMMEDIATELY CLEANED AFTER EACH PROCEDURE, RESIDUAL ORGANIC DEBRIS WILL BEGIN TO SOLIDIFY AND IT MAY BE DIFFICULT TO EFFECTIVELY REPROCESS THE ENDOSCOPE. TO PREVENT CLOGGING OF THE AIR/WATER NOZZLE, ALWAYS USE THE AW CHANNEL CLEANING ADAPTER TO CLEAN THE AIR/WATER CHANNEL AFTER EACH USE.¿ OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    CUSTOMER SENT A REPAIR REQUEST FOR "BROKEN TOE DOES NOT WASH LENS AND DOES NOT INSUFFLATE" ISSUE. THERE IS NO PATIENT INVOLVEMENT ASSOCIATED ON THIS EVENT. DEVICE RETURN EVALUATION FOUND FOREIGN MATERIAL RESIDUES INSIDE THE AW (AIR/WATER) CHANNEL FOUND. THIS REPORT IS BEING SUBMITTED FOR FOREIGN MATERIAL FOUND ON A/W CHANNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1148261 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-1TH190 04953170343360

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown