BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYSTO-NEPHRO VIDEOSCOPE

    MDR report key: 19431979 · Received May 30, 2024

    Report

    Report Number
    3002808148-2024-04928
    Event Type
    Injury
    Date Received
    May 30, 2024
    Date of Event
    May 1, 2024
    Report Date
    July 10, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FAJ
    UDI-DI
    04953170310522
    PMA / PMN Number
    K221683
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION, BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND DEVICE EVALUATION. ADDITIONALLY, TO PROVIDE CORRECTION TO THE INITIAL WITH INFORMATION INADVERTENTLY LEFT OUT (G2), TO PROVIDE AN UPDATE WITH INFORMATION RECEIVED (B5 AND D4) AND TO PROVIDE AN UPDATE TO FIELDS (H3). THE DEVICE WAS EVALUATED BY OLYMPUS. IT WAS CONFIRMED, THAT CHIP, PEELING AND FALLING OF THE ADHESIVE FROM THE SUBJECT DEVICE. THEREFORE, THE PHENOMENON INDICATED, BY THE CUSTOMER WERE REPRODUCED. 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, OLYMPUS COULD NOT CONFIRM, THE INFORMATION RELATED TO OCCURRENCE OF THE DEFECT PHENOMENON'S. HOWEVER, IT WAS CONFIRMED, THAT THE SUBJECT DEVICE HAD CHIP, PEELING AND FALLING OF THE ADHESIVE. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER- 2429304-2024-0000275. THE DEVICE EVALUATION IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED, THAT THE SECOND CYSTOSCOPY PROCEDURE WAS PERFORMED TO ENSURE ALL DEBRIS WAS URINATED OUT. IT WAS CONFIRMED, THAT ALL DEBRIS WAS OUT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SOME DEBRIS CAME OFF THE CYSTOVIDEONEPHROSCOPE DURING DIAGNOSTIC CYSTOSCOPY PROCEDURE INTO THE PATIENT'S BLADDER. THERE WERE NO REPORTS OF PATIENT INJURY, DEATH NOR ANY INFECTION. THE PROCEDURE WAS PROLONGED (UNSPECIFIED) DUE TO THE ISSUE. THERE WAS A PROCEDURAL DELAY WHILE THE DOCTOR TRIED TO BASKET THE DEBRIS OUT BUT COULD NOT CATCH THE DEBRIS IN THE NON-OLYMPUS BASKET. THE PATIENT URINATED THE DEBRIS AND IS IN "GOOD STANDING. ANOTHER CYSTOSCOPY WAS PERFORMED LAST WEEK. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS NOT AFFECTED AS A RESULT OF THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1400245 CYSTO-NEPHRO VIDEOSCOPE CYSTO-NEPHRO VIDEOSCOPE FAJ SHIRAKAWA OLYMPUS CO., LTD. CYF-VHR 04953170310522

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention NON- OLYMPUS - COOK BASKET