BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PANOVIEW

    MDR report key: 19344874 · Received May 17, 2024

    Report

    Report Number
    9611102-2024-00019
    Event Type
    Injury
    Date Received
    May 17, 2024
    Date of Event
    January 28, 2024
    Report Date
    May 17, 2024
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    FJL
    UDI-DI
    04055207055106
    PMA / PMN Number
    K041610
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION OF THE MORCESCOPE 0° 24FR WL 224MM, PART ID: 8970405, SN# (B)(6), WAS PERFORMED BY THE SPECIALIST DEPARTMENT AT RICHARD WOLF GMBH. DURING THE INSPECTION OF THE DEVICE, IT WAS FOUND THAT THERE IS MOISTURE IN THE OPTICAL SYSTEM, WHICH IS CLOUDING THE IMAGE. THE LEAK TEST REVEALED A SLIGHT LEAK IN THE CEMENTING BETWEEN THE LENS AND THE SYSTEM TUBE, ALLOWING MOISTURE TO PENETRATE AND CONTAMINATE THE OPTICAL SYSTEM. THERE ARE NO SIGNS OF IMPROPER HANDLING IN THE AREA OF THE DISTAL END SURFACE. CUSTOMER FAULT IS NOT RECOGNIZABLE IN THIS CONTEXT. THE OPTICS SHOW NORMAL SIGNS OF USE IN THE FORM OF SUPERFICIAL SCRATCHES AND A SLIGHTLY BENT ENVELOPE TUBE, WHICH HAVE NOT CAUSED ANY CONSEQUENTIAL DAMAGE. THE EXISTING TRACES OF USE PROVED THAT THE MORCESCOPE HAS BEEN USED WITHOUT ANY PROBLEMS DURING THE ENTIRE TIME WITH THE USER FACILITY. AFTER A DELIVERY PERIOD OF APPROX. 9 MONTHS, THE LEAKAGE THAT OCCURRED ON THE LENS HAS BEEN DETERMINED AS A SPORADIC FAILURE. IN GENERAL, THE USER IS ADVISED IN THE GA-D336 / EN / 2018-12 V9.0 / PK19-9377 INSTRUCTIONS FOR USE IN CHAPTER 10 THAT A VISUAL AND FUNCTIONAL CHECK MUST BE CARRIED OUT BEFORE AND AFTER EACH USE, INCLUDING WITH REGARD TO IMAGE AND LIGHT QUALITY. POSSIBLE IMAGE IMPAIRMENTS OF THE TYPE DESCRIBED ABOVE CAN BE EASILY DETECTED IF THESE INSTRUCTIONS ARE FOLLOWED. IN OUR RISK ANALYSIS A1 "REUSABLE RIGID OPTICS", REV.01, MANUFACTURING-RELATED, HANDLING-RELATED AND DESIGN-RELATED HAZARDS WITH REGARD TO FUNCTIONAL IMPAIRMENT AS WELL AS RISKS DUE TO AN UNUSABLE PRODUCT WITH THE CORRESPONDING EXTENT OF DAMAGE AND THE ASSUMED PROBABILITY OF OCCURRENCE WERE CONSIDERED AND ASSESSED WITH AN ACCEPTABLE RISK. AS NO NEW RISKS HAVE ARISEN FROM THE INVESTIGATION OF THE CURRENT COMPLAINT, THE RISK ASSESSMENT REMAINS VALID IN VIEW OF THE CIRCUMSTANCES DESCRIBED.

    Description of Event or Problem · 0

    RICHARD WOLF GMBH HAS BEEN INFORMED OF AN ISSUE REGARDING A MORCESCOPE 0° 24FR WL 224MM, PART ID: 8970405, SN# (B)(6). ACCORDING TO THE RECEIVED INFORMATION, AT THE BEGINNING OF THE PROSTATE ENUCLEATION VIA MORCELLATION, THE ATTENDING PHYSICIAN HAD PREPARED THE INSTRUMENT TO BEGIN THE PROCEDURE. UPON REACHING THE BLADDER, HIS VISION WAS EXCELLENT, BUT AFTER A SHORT TIME, VISIBILITY DETERIORATED AS THE OPTICS BECAME CLOUDY. THE INSTRUMENT WAS CHECKED AGAIN WHY THE LENS WAS CLOUDY. HOWEVER, OPTICS REMAIN FOGGY. UNDER THESE CONDITIONS, THE DOCTOR COMPLETED THE PROCEDURE WITH DIFFICULTY. IN ADDITION, THIS LED TO A PROLONGED SURGERY AND EXTENDED ANESTHESIA TIME OF ONE (1) HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2530139 PANOVIEW MORCESCOPE 0° 24FR WL 224MM FJL RICHARD WOLF GMBH 8970405 04055207055106

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other