BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E-LINE URETERORENOSKOP 5° 6/7,5CH NL 430MM

    MDR report key: 13455526 · Received February 4, 2022

    Report

    Report Number
    9611102-2022-00004
    Event Type
    Malfunction
    Date Received
    February 4, 2022
    Date of Event
    December 22, 2021
    Report Date
    February 3, 2022
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    FGB
    UDI-DI
    04055207020012
    PMA / PMN Number
    K062720
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) SUBMITTING REPORT ON BEHALF OF RWGMBH REPORT ON BEHALF OF RWGMBH. ACCORDING TO THE MANUFACTURER, RW GMBH: TTHE 8703534 URETERORENOSCOPE 12° 8/9.8CH NL 430MM WITH SERIAL NUMBER (B)(4) FROM LOT 1473065 WAS EXAMINED BY RICHARD WOLF. VISUAL AND FUNCTIONAL EXAMINATION REVEALED NO DEFECT. THE URETERORENOSCOPE WAS MANUFACTURED WITH PRODUCTION ORDER (B)(4) AND BOOKED INTO STOCK ON 05.03.2021. THE PRODUCTION ORDER CONSISTS OF A TOTAL OF (B)(4) PIECES. THE URETERORENOSCOPE WAS DELIVERED TO THE CUSTOMER WITH DELIVERY BILL (B)(4) ON 04/06/2021. ACCORDING TO SAP, NO REPAIRS HAVE BEEN CARRIED OUT ON THE URETERORENOSCOPE TO DATE. IN GENERAL, THE USER IS ADVISED IN THE ASSOCIATED INSTRUCTIONS FOR USE GA-D352 / EN / 2018-12 V6.0 / PK18-9377 UNDER CHAPTER 8 THAT A VISUAL AND FUNCTIONAL CHECK MUST BE PERFORMED BEFORE AND AFTER EACH USE. POSSIBLE IMAGE IMPAIRMENTS OF THE ABOVE TYPECAN BE EASILY DETECTED BY HOSPITAL STAFF IF THESE INSTRUCTIONS ARE FOLLOWED. A MORE DETAILED REVIEW OF THE COMPLAINTS DATABASE (SAP) WAS PERFORMED FOR THE PERIOD 01/01/2018 TO 03/02/2022. DURING THIS PERIOD, THE 8703534 URETERORENOSCOPE 12° 8/9.8CH NL 430MM WAS SOLD (B)(4) TIMES, DURING THE PERIOD UNDER REVIEW, THE URETERORENOSCOPE WAS COMPLAINED (B)(4) TIMES, THERE IS NO SIMILAR CASE. CONSEQUENTLY, NO FURTHER ACTION IS BEING TAKEN ON THIS INCIDENT AT THIS TIME, OTHER THAN MONITORING ADDITIONAL CASES TO DETERMINE A POSSIBLE TREND. IN OUR A1-2 R05 RISK ANALYSIS, MANUFACTURING-RELATED, HANDLING-RELATED AND DESIGN-RELATED HAZARDS WITH REGARD TO A FUNCTIONAL IMPAIRMENT SUCH AS DETERIORATION OF IMAGE QUALITY, AS WELL AS RISKS DUE TO AN UNUSABLE PRODUCT WITH THE CORRESPONDING EXTENT OF DAMAGE AND ASSUMED PROBABILITY OF OCCURRENCE WERE CONSIDERED AND RATED AS AN ACCEPTABLE RISK. WE CAN EXCLUDE THE POSSIBILITY OF A PRODUCT OR MANUFACTURING DEFECT. RICHARD WOLF GMBH (RWGMBH) CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT RWGMBH RECEIVES ANY ADDITIONAL INFORMATION A FOLLOW UP REPORT WILL BE SUBMITTED TO FDA. RICHARD WOLF MEDICAL INSTRUMENTS CORPORA-TION (RWMIC) SUBMITTING REPORT ON BEHALF OF RWGMBH REPORT ON BE-HALF OF RWGMBH.

    Description of Event or Problem · 0

    IT WAS REPORTED TO RICHARD WOLF GMBH. "DURING THE FIRST TEST, THE DOCTOR AND THE BIOMEDICAL ENGINEERS CAN SEE THAT THE VISION OF THE URETERO RENOSCOPE IS BAD, THE IMAGE IS BLURRED .THE TREATMENT WAS DELAYED BY THIS INCIDENT OR HAD TO BE DISCONTINUED BECAUSE NO OTHER URETHOSCOPE WAS AVAILABLE. THERE WAS NO RISK TO THE PATIENT OR HEALTH.."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1235058 E-LINE URETERORENOSKOP 5° 6/7,5CH NL 430MM URETERORENOSKOP 5° 6/7,5CH NL 430MM FGB RICHARD WOLF GMBH 8702524 1473065 04055207020012

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown NOT REPORTED