BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANOVIEW PLUS HD

    MDR report key: 16387151 · Received February 16, 2023

    Report

    Report Number
    9611102-2023-00007
    Event Type
    Malfunction
    Date Received
    February 16, 2023
    Date of Event
    December 21, 2022
    Report Date
    February 16, 2023
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    HRX
    UDI-DI
    04055207035054
    PMA / PMN Number
    D274504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE INSPECTION OF THE DISKOSKOP 25° Ø 6,9MM SL 207MM, PART NO. 89211254, SERIAL #(B)(4) BY RICHARD WOLF GMBH, IT WAS DETERMINED IN ACCORDANCE WITH TEST INSTRUCTIONS THAT THERE WAS MOISTURE IN THE OPTICAL SYSTEM, WHICH CAUSED CLOUDY VISION. AFTER A PERIOD OF USE OF APPROX. 18 MONTHS AND SINCE NEITHER THE SEALING RING NOR THE SEALING SURFACES SHOW ANY ABNORMALITIES/DAMAGE, IT IS ASSUMED THAT THE SEAL BETWEEN THE CLADDING TUBE AND THE FUNNEL HOLDER HAS FAILED SPORADICALLY. THE DISKOSKOP WAS PRODUCED ON 10/JUN/2021, THE PRODUCTION ORDER CONSISTED OF 8 DISCOSCOPES. THE SUBJECT DISCOSCOPE WAS DELIVERED TO THE CUSTOMER ON 16/JUN/2021. THE IFU GA-B 223 / USA / 2012-10 V5.0 / ECO 2012-0519 CONTAINS SEVERAL DESCRIPTIONS OF VISUAL AND FUNCTIONAL CHECKS WHICH SERVE TO DETECT FAULTS PRIOR TO USE ON PATIENT IN SECTION 6 USE AND SECTION 7 CHECK. IN ADDITION THE IFU STATES THAT THE PRODUCT MUST BE CHECKED FOR DAMAGE, LOOSE PARTS AND COMPLETENESS IMMEDIATELY BEFORE AND AFTER USE. THE SUBJECT ISSUE OF CLOUDY / OBSCURED OPTICS IS PRESENT IN THE RISK MANAGEMENT FILE A1 - REUSABLE RIGID TELESCOPES 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 REPORTED THE FOLLOWING: DUE NO VISION OF THE OPTIC DURING THE ENDOSCOPIC SPINE SURGERY, THE SURGEON TOOK THE DECISION MAKE OPEN SPINE SURGERY. EXTERNALLY THE OPTIC LOOKS LIKE NEW, BUT COMPLETELY DARK VISION, THE CLIENT DEMANDS AN EXPLANATION, REPAIR OR REPLACEMENT OF THE LENS. "WITHOUT VISION OF THE OPTIC 89210.1254, THE ENDOSCOPIC SPINE SURGERY FAILED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359561 PANOVIEW PLUS HD DISCOSCOPE 25° Ø 6.9MM SL 207MM HRX RICHARD WOLF GMBH 892101254 04055207035054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other