BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE

    MDR report key: 19189980 · Received April 26, 2024

    Report

    Report Number
    9610773-2024-30181
    Event Type
    Malfunction
    Date Received
    April 26, 2024
    Date of Event
    March 26, 2024
    Report Date
    June 28, 2024
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HET
    PMA / PMN Number
    K111788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS CONFIRMED. IN ADDITION, THE FOLLOWING REPORTABLE MALFUNCTION IDENTIFIED DURING THE DEVICE EVALUATION: THE FIBER BONDING IN THE OUTER TUBE AREA (DISTAL END) IS DAMAGED. THE MOST PROBABLE CAUSE OF THE COMPLAINT IS COMPONENT FAILURE. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: THE VIDEO CABLE IS BROKEN AND THEREFORE STRIPES IN IMAGE OCCUR. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE FIBER BONDING IN THE OUTER TUBE AREA (DISTAL END) BEING DAMAGED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED TO OLYMPUS. THE EVALUATION OF THE EVENT 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

    IT WAS REPORTED, THE RIGID VIDEO SCOPE HAD DISTURBANCES IN THE PICTURE. THE ISSUE OCCURRED DURING PREPARATION FOR USE AND THE UNSPECIFIED THERAPEUTIC PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORT OF PATIENT HARM ASSOCIATED WITH THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE RIGID VIDEO SCOPE HAD DISTURBANCES IN THE PICTURE. THE ISSUE OCCURRED DURING PREPARATION FOR USE AND THE UNSPECIFIED THERAPEUTIC PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORT OF PATIENT HARM ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2123228 VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE LAPAROSCOPE, GYNECOLOGIC HET OLYMPUS WINTER & IBE GMBH WA50042A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CLV-190 LIGHT SOURCE.| CV-190 VIDEO PROCESSOR.