BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA LAPARO-THORACO VIDEOSCOPE

    MDR report key: 16885214 · Received May 8, 2023

    Report

    Report Number
    9610595-2023-07193
    Event Type
    Malfunction
    Date Received
    May 8, 2023
    Report Date
    May 21, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    GCJ
    PMA / PMN Number
    K955403
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE CUSTOMER'S ALLEGATION WAS CONFIRMED. THE DEVICE EVALUATION FOUND THE FOLLOWING: A) DUE TO DAMAGE ON OBJECTIVE LENS, A FOGGY IMAGE OCCURS, B) BENDING SECTION COVER OR DISTAL SHEATH HAS A SCRATCH, C) VIDEO CONNECTOR CASE HAS A SCRATCH, D) ADHESIVE AROUND OBJECTIVE LENS IS PEELED, E) VIDEO CONNECTOR CASE HAS A SCRATCH, F) VIDEO CABLE HAS A SCRATCH, G) LIGHT GUIDE CONNECTOR HAS A SCRATCH, H) LIGHT GUIDE COVER GLASS HAS A SCRATCH, I) FORCEPS ELEVATOR LEVER(SURGICAL PRODUCT) HAS DISCOLORATION, J) FORCEPS ELEVATOR LEVER(SURGICAL PRODUCT) IS DIRTY, K) RIGHT/LEFT PLATE HAS DISCOLORATION, L) RIGHT/LEFT PLATE HAS A SCRATCH, M) UP/DOWN PLATE HAS DISCOLORATION, N) UP DOWN PLATE HAS A SCRATCH, O) GRIP HAS DISCOLORATION, P) SWITCH1 HAS DISCOLORATION, Q) SWITCH HAS A SCRATCH, R) BENDING SECTION COVER OR DISTAL SHEATH HAS A CHIP, S) ADHESIVE AROUND OBJECTIVE LENS IS PEELED, AND T) OBJECTIVE LENS IS SHAVED. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    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, IT IS LIKELY THAT THE DEFECT WAS CAUSED BY STRESS OF REPEATED USE, EXTERNAL FACTORS, OR HANDLING. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: "CHAPTER 3 PREPARATION AND INSPECTION, 3.2 INSPECTION OF THE ENDOSCOPE. 1. INSPECT THE OBJECTIVE LENS AND LIGHT-GUIDE COVER GLASS AT THE DISTAL END OF THE ENDOSCOPE¿S INSERTION SECTION FOR SCRATCHING, CRACKS, STAINS, GAPS AROUND THE LENS, OR OTHER IRREGULARITIES. 2. INSPECT THE SURFACE OF THE INSERTION SECTION FOR CRACKS, DENTS, BULGES, OR OTHER IRREGULARITIES. 3. INSPECT THE COVERING OF THE BENDING SECTION FOR SAGGING, SWELLING, CUTS, HOLES, OR OTHER IRREGULARITIES. 4. CAREFULLY RUN YOUR FINGERTIPS OVER THE ENTIRE LENGTH OF THE INSERTION SECTION. CHECK FOR PROTRUDING OBJECTS OR OTHER IRREGULARITIES. 5. INSPECT THE CONTROL SECTION, LIGHT GUIDE CONNECTOR AND VIDEO PLUG FOR EXCESSIVE SCRATCHING, WHICH MAY ALLOW DEBRIS TO ACCUMULATE. 6. INSPECT THE GLUE ON BOTH ENDS OF THE COVERING OF THE BENDING SECTION FOR SCRATCHING, CHIPS, CRACKS, OR OTHER IRREGULARITIES. CHAPTER 3 PREPARATION AND INSPECTION, 3.6 INSPECTION OF THE ENDOSCOPIC SYSTEM. 1. BEFORE INSPECTION, WIPE THE OBJECTIVE LENS USING A CLEAN, LINT-FREE CLOTH. 2. TURN ON THE VIDEO SYSTEM CENTER, LIGHT SOURCE, MONITOR AND INSPECT THE ENDOSCOPIC IMAGE AS DESCRIBED IN THEIR RESPECTIVE INSTRUCTION MANUALS. 3. ADJUST THE BRIGHTNESS LEVEL AS APPROPRIATE. 4. WHILE OBSERVING THE PALM OF YOUR HAND, CONFIRM THAT THE EXAMINATION LIGHT IS ON AND WORKING AND THAT THE ENDOSCOPIC IMAGE IS FREE FROM NOISE, BLUR, FOG OR OTHER IRREGULARITIES. 5. ANGULATE THE ENDOSCOPE AND CONFIRM THAT THE ENDOSCOPIC IMAGE IS FREE FROM MOMENTARY FLICKERING, DISAPPEARING IMAGES, OR OTHER IRREGULARITIES." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE FIELD OF VIEW OF THE VISCERA LAPARO-THORACO VIDEOSCOPE WAS CLOUDY DUE TO THE DAMAGE OF THE OBJECTIVE LENS. THE ISSUE WAS FOUND WHEN PREPARING THE SCOPE FOR USE IN A THERAPEUTIC PROCEDURE. THE CUSTOMER NOTED THE ISSUE HAD PREVIOUSLY OCCURRED AND THE DEVICE WAS REPAIRED. THE DEVICE WAS NOT USED FOR A LONG, BUT THE SAME ISSUE OCCURRED AGAIN. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600216 VISERA LAPARO-THORACO VIDEOSCOPE LAPARO-THORACO VIDEOSCOPE GCJ AIZU OLYMPUS CO., LTD. LTF-VP

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown