BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELESCOPE, 70°, 4 MM

    MDR report key: 22794372 · Received August 13, 2025

    Report

    Report Number
    9610773-2025-05090
    Event Type
    Malfunction
    Date Received
    August 13, 2025
    Date of Event
    August 8, 2025
    Report Date
    August 13, 2025
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HIH
    UDI-DI
    04042761020862
    PMA / PMN Number
    K897003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS REPORTED BECAUSE NO IMAGE. THE OLYMPUS SERVICE TEAM RECEIVED A A22003A FOR THE REPORTED ISSUE OF "NO IMAGE". AS A PART OF THE ESTIMATION PROCESS, THIS DEVICE UNDERWENT A VISUAL INSPECTION AND FUNCTIONAL TESTS TO ASSESS THE DEVICE STATUS. THE USER REQUEST FOR "NO IMAGE" WAS CONFIRMED, THERE IS NO IMAGE. ADDITIONALLY, THE OUTER TUBE INS BENT. A LABELING REVIEW IS NOT REQUIRED AS THERE IS NO EVIDENCE TO SUGGEST THAT THE USER MAY NOT HAVE PROPERLY HANDLED/USED THE DEVICE IN ACCORDANCE WITH THE IFU. A DHR REVIEW IS NOT REQUIRED AS THE COMPLAINT CAUSE IS NOT TRACED TO MANUFACTURING, PACKAGING OR LABELING A RISK REVIEW WAS PERFORMED FOR "A040609 AND A090206" BASED ON HISTORICAL DATA AND NO UNANTICIPATED RISKS, NEW FAILURES, AND/OR NEW HARMS WERE IDENTIFIED. A HISTORICAL REVIEW OF THE LAST 12 MONTHS OF COMPLAINTS WAS PERFORMED FOR "A090206" AND NO TRENDS WERE IDENTIFIED. A CAPA HISTORY REVIEW WAS PERFORMED FOR "A040609 AND A090206" AND NO RELATED CAPAS WERE FOUND. THE COMPLAINT ALLEGATION FOR "NO IMAGE" WAS CONFIRMED, THERE IS NO IMAGE. THE MOST PROBABLE CAUSE OF THE COMPLAINT IS D02, WHICH IS CAUSE TRACED TO COMPONENT FAILURE. NO FURTHER ESCALATION IS REQUIRED.

    Description of Event or Problem · 0

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE OUTER TUBE IS BENT. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76057 TELESCOPE, 70°, 4 MM A22003A HIH OLYMPUS WINTER & IBE GMBH A22003A 04042761020862

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown