BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYSTO-NEPHRO VIDEOSCOPE

    MDR report key: 17035605 · Received May 31, 2023

    Report

    Report Number
    3002808148-2023-05481
    Event Type
    Malfunction
    Date Received
    May 31, 2023
    Report Date
    July 31, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FAJ
    UDI-DI
    04953170310461
    PMA / PMN Number
    K221683
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    501

    Narratives

    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, THE ROOT CAUSE OF THE SUGGESTED EVENT COULD NOT BE CONCLUDED. THE EVENT CAN BE DETECTED/PREVENTED, BY FOLLOWING THE FOLLOWING WARNING IN THE INSTRUCTIONS FOR USE: IMPORTANT INFORMATION: PLEASE READ BEFORE USE WARNINGS AND CAUTIONS. [WARNING]: DO NOT STRIKE, HIT OR DROP THE ENDOSCOPE¿S DISTAL END, INSERTION TUBE, BENDING SECTION, CONTROL SECTION, UNIVERSAL CORD, VIDEO CONNECTOR OR LIGHT GUIDE CONNECTOR. ALSO, DO NOT BEND, PULL OR TWIST THE ENDOSCOPE¿S DISTAL END, INSERTION TUBE, BENDING SECTION, CONTROL SECTION, UNIVERSAL CORD, VIDEO CONNECTOR OR LIGHT GUIDE CONNECTOR WITH EXCESSIVE FORCE. THE ENDOSCOPE MAY BE DAMAGED AND COULD CAUSE PATIENT INJURY, BURNS, BLEEDING AND/OR PERFORATIONS. IT COULD ALSO, CAUSE PARTS OF THE ENDOSCOPE TO FALL OFF INSIDE THE PATIENT. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    TO DATE, THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. 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.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED TO OLYMPUS, THE TIP OF THE CYSTO-NEPHRO VIDEOSCOPE WAS DAMAGE WHILE AT THE HEALTHCARE STERILE PROCESSING ASSOCIATION (HSPA) TRADE SHOW. THE TIPS ARE CHIPPING AWAY. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR HARM ASSOCIATED WITH THIS EVENT. EVENT 3 OF 5: THIS REPORT IS BEING SUBMITTED FOR A CYSTO-NEPHRO VIDEOSCOPE, ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6). THE 4 REMAINING CYSTO-NEPHRO VIDEOSCOPES WERE REPORTED UNDER THE FOLLOWING MEDWATCH PATIENT IDENTIFIERS: (B)(6), (B)(6), (B)(6), AND (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1837074 CYSTO-NEPHRO VIDEOSCOPE CYSTO-NEPHRO VIDEOSCOPE FAJ SHIRAKAWA OLYMPUS CO., LTD. CYF-VH 04953170310461

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown