BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO TELESCOPE "ENDOEYE HD II", 5.4 MM, 30°, AUTOCLAVABLE

    MDR report key: 19801711 · Received July 22, 2024

    Report

    Report Number
    9610773-2024-31791
    Event Type
    Malfunction
    Date Received
    July 22, 2024
    Date of Event
    June 21, 2024
    Report Date
    January 2, 2025
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HET
    UDI-DI
    04042761075015
    PMA / PMN Number
    K190744
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. UPDATED FIELDS: D8, H2, H3, H4, H6, H11. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS CONFIRMED. IN ADDITION, THE FOLLOWING REPORTABLE MALFUNCTIONS WERE IDENTIFIED DURING THE DEVICE EVALUATION: -INTERNAL CORROSION IN INSERTION TUBE. -INSERTION TUBE IS DENT. -INSERTION TUBE IS BEND. -LIGHT GUIDE BUNDLE IS BROKEN. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: CAUSED BY A COMPONENT FAILURE OF VIDEO CONNECTOR COVER. THE CAUSE OF VIDEO CONNECTOR COVER FAILURE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER. THE INTENDED PROCEDURE WAS COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE THE SUBJECT DEVICE PRESENTED A DAMAGE ON ITS UNIVERSAL CONNECTING SECTION. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    935647 VIDEO TELESCOPE "ENDOEYE HD II", 5.4 MM, 30°, AUTOCLAVABLE RIGID VIDEO LAPAROSCOPE HET OLYMPUS WINTER & IBE GMBH WA50052A 04042761075015

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown