BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOA VISION

    MDR report key: 16385090 · Received February 16, 2023

    Report

    Report Number
    9611102-2023-00003
    Event Type
    Malfunction
    Date Received
    February 16, 2023
    Report Date
    May 4, 2023
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    FGB
    UDI-DI
    04055207054840
    PMA / PMN Number
    K183188
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NEW INFORMATION: B4, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS), H7, AND H10. CORRECTED DATA: H4. PATIENT INFORMATION: THE USER FACILITY WAS CONTACTED SEVERAL TIMES IN AN EFFORT TO COLLECT PATIENT INFORMATION. THE SALES REPRESENTATIVE CONFIRMED NO FURTHER PATIENT INFORMATION WAS OBTAINABLE. DEVICE EVALUATION: THE SENSOR-URETERORENOSCOPE 8.7FR WL 680MM, PART NO. 7355071, S/N (B)(6), WAS INVESTIGATED IN THE RESPONSIBLE DEPARTMENT. THE VISUAL AND FUNCTIONAL INVESTIGATION REVEALED THAT THE DISTAL HOSE WAS OVERLAPPED. THE PROBABLE ROOT CAUSE OF THE FINDINGS CANNOT BE EXACTLY DETERMINED, BECAUSE NO INFORMATION IS AVAILABLE HOW MANY TIMES THE REPORTED DEVICE WAS USED, REPROCESSED BY THE USER FACILITY SINCE DELIVERY AND WHICH REPROCESSING METHOD WAS USED. HOWEVER, THE DAMAGE PATTERN INDICATES IMPROPER HANDLING DURING REPROCESSING. THE SENSOR-URETERORENOSCOPE 8.7FR WL 680MM, PART NO. 7355071, SERIAL # (B)(6) WAS MANUFACTURED ON 23/SEP/2020. NO ISSUES WERE IDENTIFIED DURING PRODUCTION, NO FURTHER COMPLAINTS WERE RECEIVED REGARDING THIS ISSUE. THE IFU GA-D396 / EN-US / 2020-11 V1.0 / PK20-0024 CONTAINS SEVERAL INSTRUCTIONS OF VISUAL AND FUNCTIONAL CHECKS PRIOR AND AFTER EACH USE IN SECTION 8 CHECKS. FURTHERMORE, THE USER IS ADVISED ABOUT THE PROPER HANDLING OF THE DEVICE IN SECTION 9 PROCESSING PROCEDURE. THE SUBJECT ISSUE OF FUNCTIONAL IMPAIRMENT/TRAUMATIZING GEOMETRY AS WELL AS HAZARD DUE TO WORKING CONDITIONS AND RESTRICTED FREEDOM OF MOVEMENT IS PRESENT IN THE RISK MANAGEMENT FILE A4: REUSABLE FLEXIBLE VIDEO OPTICS WITH AND WITHOUT WORKING CHANNEL, REV.: 05. THE OVERALL PROBABILITY OF OCCURRENCE FOR THIS ISSUE REMAINS AT PREVIOUSLY DEFINED LEVELS AND OVERALL RISK OF THE DEVICE REMAINS IN THE ACCEPTABLE CATEGORY.

    Description of Event or Problem · 0

    THE USER FACILITY REPRESENTATIVE REPORTED THAT SENSOR-URETERORENOSCOPE 8.7FR WL 680MM, PART NO. 7355071, SERIAL NO. (B)(4), DEFLECTION COVER BUNCHED UP AND THE SURGEON COULD NOT PULL THE SCOPE THROUGH THE ACCESS SHEATH AND URETER. THE PRIMARY SURGEON NEEDED TO CALL A PARTNER WHO WAS ABLE TO HELP REMOVE THE SCOPE. THE SECONDARY UROLOGY (THE SPECIALIST) DIDN'T SEEM UPSET ABOUT THE ISSUES. I AM NOT SURE WHY THE DEFLECTION COVER BUNCHED UP. ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER FACILITY REPRESENTATIVE ON JANUARY 20, 2023. ACCORDING TO THE RECEIVED INFORMATION, THERE WAS A DELAY OF 45 MINUTES IN THE PROCEDURE AND A FOLLOW-UP PROCEDURE IS NECESSARY TO COMPLETE THE SCHEDULED AND PLANNED TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385571 BOA VISION SENSOR-URETERORENOSCOPE 8.7FR WL 680MM FGB RICHARD WOLF GMBH 7355071 04055207054840

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown