BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E-LINE

    MDR report key: 17920799 · Received October 12, 2023

    Report

    Report Number
    9611102-2023-00058
    Event Type
    Injury
    Date Received
    October 12, 2023
    Date of Event
    August 5, 2023
    Report Date
    October 12, 2023
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    FGB
    UDI-DI
    04055207020036
    PMA / PMN Number
    K062720
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXAMINATION HAS REVEALED THAT MOISTURE HAS PENETRATED INTO SYSTEM AT THE SEALING RING. THE URETERORENOSCOPE 5° 6/7.5FR WL 430MM, PART ID: 8702534, SERIAL # (B)(6), WAS PRODUCED ON (B)(6) 2022 IN A LOT OF (B)(4) PIECES. UNTIL TODAY, THIS IS THE ONLY S/N (B)(6) FROM THIS LOT WHICH WAS CLAIMED WITH THIS ERROR PATTERN. THE DEFECT IS CONSIDERED AS A SPORADIC FAILURE. IN THE LAST THREE YEARS, A TOTAL OF 6 COMPLAINTS WERE PROCESSED FOR THIS TYPE, WHICH WERE ALSO CLASSIFIED AS SPORADIC FAILURES. AT THE SAME TIME, (B)(4) TYPES WERE SOLD WORLDWIDE. BASED ON THIS DATA, WE DO NOT SEE ANY FUNDAMENTAL PROBLEM, THE INSTRUMENT CORRESPONDS TO THE CURRENT STATE OF THE ART. THE IFU GA-D 352 /USA/ 2012-11 V4.0 I ECO: 2012-0540 CONTAINS SEVERAL DESCRIPTIONS OF VISUAL AND FUNCTIONAL CHECKS WHICH SERVE TO DETECT FAULTS PRIOR TO USE ON PATIENT IN SECTION 7 USE AND SECTION 8 CHECKS. IN ADDITIONAL, THE IFU STATES THAT THERE MUST ALWAYS BE AN OPERABLE COMPARABLE DEVICE OR A CONVENTIONAL SYSTEM ON HAND. THE SUBJECT ISSUE OF IMAGE FAILURE IS PRESENT IN THE RISK MANAGEMENT FILE A1 - REUSABLE RIGID 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 HAS INFORMED RICHARD WOLF GMBH OF AN ISSUE REGARDING A URETERORENOSCOPE 5° 6/7.5FR WL 430MM, PART ID: 8702534, SERIAL NUMBER # (B)(6). SURGERY PLANNED ON AUGUST 5, 2023, RESOLUTION OF PATIENT CASE WITH URETERAL LITHIASIS, URETERAL LITHOTRIPSY SURGERY IS PLANNED USING RICHARD WOLF URETERORENOSCOPE 5° 6/7.5FR. ACCORDING TO THE INITIAL REPORTER, THE PROCEDURE BEGINS, PERCEIVING POOR IMAGE QUALITY AT THE BEGINNING OF THE PROCEDURE, WITH THE PRESENCE OF AN EXTERNAL HALO THAT REDUCES THE FIELD OF VISION, MAKING MANEUVERS WITHIN THE URETER DIFFICULT. AN ATTEMPT IS MADE TO PERFORM LITHOTRIPSY WITH A PNEUMATIC LITHOTRIPTER; DUE TO VISION DIFFICULTIES, IT IS DECIDED TO SUSPEND PROCEDURE AND RESCHEDULE THE CASE UNTIL A NEW WORK ITEM IS AVAILABLE, EXPOSING THE PATIENT AGAIN TO ANOTHER ANESTHETIC EVENT AND ANOTHER HOSPITALIZATION. THERE WAS A TIME DELAY ABOUT 90 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1505508 E-LINE URETERORENOSCOPE 5° 6/7.5FR WL 430MM FGB RICHARD WOLF GMBH 8702534 04055207020036

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other