BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANOVIEW

    MDR report key: 11895248 · Received May 27, 2021

    Report

    Report Number
    9611102-2021-00021
    Event Type
    Malfunction
    Date Received
    May 27, 2021
    Date of Event
    May 5, 2021
    Report Date
    May 27, 2021
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    GCM
    UDI-DI
    04055207018804
    PMA / PMN Number
    K993103
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP REPORT #1 IS TO PROVIDE FDA WITH RESULTS OF THE DEVICE EVALUATION PLUS NEW INFORMATION AND CHANGED INFORMATION. THE FOLLOWING FIELDS HAVE NEW OR CHANGED INFORMATION: B5, D8, G2, G3, G6, H3, H5, H7, H10O. THE RESULTS OF THE DEVICE EVALUATION: THE TELESCOPE 12° Ø 4MM WL 297MM WAS CHECKED AT RW GMBH IN (B)(6). DUE TO LEAKAGE, MOISTURE HAS PENETRATED THE OPTICAL SYSTEM. THIS HAS LED TO CLOUDING THE IMAGE. ATTEMPTS BY THE USER TO IMPROVE THE IMAGE QUALITY BY CLEANING THE TELESCOPE WERE UNSUCCESSFUL. THEN THE USER DECIDED TO CANCEL THE SURGERY AND PERFORM ANOTHER SURGERY LATER. CAUSES AND REASONS, WHY NO REPLACEMENT OF THE TELESCOPE WAS AVAILABLE, ARE UNKNOWN. THE USER IS INFORMED IN THE IFU GA-S001 / EN-US / 2017-03 V3.0 / (B)(4) ABOUT THE VISUAL AND FUNCTIONAL CHECKS BEFORE AND AFTER EACH USE: SECTION 7 APPLICATION CAUTION! THE PRODUCTS HAVE ONLY LIMITED STRENGTH! EXCESSIVE FORCE WILL CAUSE DAMAGE, IMPAIR THE FUNCTION AND THEREFORE ENDANGER THE PATIENT. IMMEDIATELY BEFORE AND AFTER EACH USE, CHECK THE PRODUCTS FOR DAMAGE, LOOSE PARTS AND COMPLETENESS. MAKE SURE THAT NO MISSING PARTS REMAIN IN THE PATIENT. DO NOT USE THE PRODUCTS IF THEY ARE DAMAGED OR INCOMPLETE OR HAVE LOOSE PARTS. SECTION 7.2.3 IMAGE QUALITY CAUTION! INCREASED RISK POTENTIAL IF THE IMAGE IS BLURRED! DANGER OF INJURING THE PATIENT. STOP THE INTERVENTION FOR SAFETY REASONS IF THE IMAGE IS BLURRED. CHECK THE IMAGE QUALITY OF THE ENDOSCOPE BEFORE USE (SECTION 8.2). SECTION 8.2 FUNCTION CHECK . CHECK IMAGE QUALITY AND LIGHT OUTPUT IN CONJUNCTION WITH THE SYSTEM COMPONENTS. - CHECK THE GLASS SURFACES FOR ANY DEPOSITS. - DEPOSITS ON THE GLASS SURFACES CAN CAUSE A SPOTTED OR BLURRED FIELD OF VIEW AND HENCE IMPAIR LIGHT TRANSMISSION CONSIDERABLY. - CLEAN THE GLASS SURFACES WITH A SWAB SOAKED WITH ALCOHOL (WOODEN SWAB CARRIER, NOT METAL OR PLASTIC) AND HARD-TO-REMOVE DEPOSITS WITH A SUITABLE INSTRUMENT CLEANER. - CHECK THE LIGHT OUTPUT WITHOUT THE SYSTEM COMPONENTS. - HOLD THE DISTAL END OF THE ENDOSCOPE TOWARDS A LIGHT SOURCE. - BROKEN FIBERS APPEAR AS BLACK DOTS AT THE COLD-LIGHT CONNECTOR. IF APPROX. 30% OF THE FIBERS ARE BROKEN, THE LIGHT OUTPUT IS NO LONGER SUFFICIENT. POTENTIAL HAZARD DUE TO DEGRADATION OF IMAGE TRANSMISSION WERE CONSIDERED IN THE RISK ASSESMENT A1, REV. 05 REUSABLE RIGID TELESCOPES WITH AND WITHOUT WORKING CHANNEL WITH THE CORRESPONDING EXTEND OF DAMAGE AND PROBABILITY OF OCCURRENCE, AND WERE RATED AS ACCEPTABLE RISK. THIS ASSESSMENT IS STILL VALID EVEN CONSIDERING THE CURRENT CASE. IN VIEW OF RW GMBH, AN USER ERROR LED TO THE CANCELLATION OF THE SURGERY. THE TELESCOPE SHALL HAVE BEEN CHECKED BEFORE AND AFTER EACH USE. FURTHER CHECKS SHALL ALSO PERFORMED DURING REPROCESSING THE INSTRUMENT. IF ALL THESE CHECKS WOULD HAVE BEEN PERFORMED ACCORDING TO THE MANUFACTURER'S INSTRUCTIONS, THE LEAKING TELESCOPE SHOULD NOT HAVE BEEN USED IN THE TREATMENT AT ALL. RWMIC IS SUBMITTING THIS REPORT ON BEHALF OF RICHARD WOLF GMBH. A NEW REPORT WILL BE SUBMITTED IF NEW INFORMATION BECOMES AVAILABLE. RW GMBH CONSIDERS THIS MDR CLOSED.

    Description of Event or Problem · 0

    SEE MANUFACTURERS NARRATIVE FOR RESULTS OF THE DEVICE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    RWMIC IS SUBMITTING THIS REPORT ON BEHALF OF RICHARD WOLF (B)(4). RW (B)(4) IS IN THE PROCESS OF INVESTIGATING THIS COMPLAINT. A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    THE USER DESCRIBES THE INCIDENT AS FOLLOWS: "NEU OPTIC OF OUR OPERATIVE HYSTEROSCOPE (RESECTOSCOPE) IS DEFECTIVE. UNFORTUNATELY, I HAD TO REALIZE THIS DURING THE TREATMENT THAT THE IMAGE IS VERY BLURRY, I CAN ONLY RECOGNIZE THE OBJECTS HAZY AS IT WAS THROUGH A FROSTED GLAZE. I HAD TO CANCEL THE SURGERY BECAUSE THERE WAS NO SHARP IMAGE POSSIBLE." RICHARD WOLF (B)(4) COMPLAINT REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795663 PANOVIEW TELESCOPE 12° Ø 4MM WL 297MM RIGID GCM RICHARD WOLF GMBH 8654431 04055207018804

    Patients

    Seq Age Sex Outcome Treatment
    1 Other