BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIPER

    MDR report key: 22507234 · Received July 15, 2025

    Report

    Report Number
    1418479-2025-00006
    Event Type
    Malfunction
    Date Received
    July 15, 2025
    Date of Event
    July 2, 2025
    Report Date
    July 15, 2025
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Product Code
    FAJ
    UDI-DI
    04055207013694
    PMA / PMN Number
    K980401
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THERE HAS BEEN NO REPORT OF INJURY TO THE PATIENT. THE REPORTED ISSUE DID NOT CAUSE ANY CRITICAL DELAY OR POSE ANY UNACCEPTABLE RISK. HOWEVER, RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) HAS SUBMITTED A COMPARABLE REPORTABLE SERIOUS INCIDENT IN THE PAST TWO YEARS AND THEREFORE HAVE CONSIDERED TO REPORT THIS CASE TO BE A REPORTABLE MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A CYSTOSCOPY WITH LASER LITHOTRIPSY, THE COATING AT THE TIP OF THE SCOPE IS BUNCHED UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1771666 VIPER FIBER-URETERORENOSCOPE 9.6FR WL 680MM FAJ RICHARD WOLF MEDICAL INSTRUMENTS CORP. 7325071 04055207013694

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown