BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19483893 · Received June 7, 2024

    Report

    Report Number
    9610773-2024-30994
    Event Type
    Malfunction
    Date Received
    June 7, 2024
    Report Date
    October 21, 2024
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HET
    UDI-DI
    04042761074971
    PMA / PMN Number
    K111788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE, "GREEN IMAGE" WAS CONFIRMED. IN ADDITION, THE FOLLOWING REPORTABLE MALFUNCTIONS WERE IDENTIFIED DURING THE DEVICE EVALUATION: THE FIBER BONDING IN THE OUTER TUBE AREA (DISTAL END) IS DAMAGED AND THE RIGHT UNIT IS BROKEN. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION FOR THE: THE R-UNIT (CHARGED COUPLED DEVICE) IS BROKEN AND THE FIBER BONDING IN THE OUTER TUBE AREA (DISTAL END) IS DAMAGED, THE MOST PROBABLE CAUSE OF THE IDENTIFIED FAILURES IS CAUSE NOT ESTABLISHED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A THERAPEUTIC LAPAROSCOPIC APPENDECTOMY PROCEDURE, THE SUBJECT DEVICE HAD GREEN IMAGE AND ERROR E104: FOG-FREE FUNCTION WAS NOT WORKING. A SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A THERAPEUTIC LAPAROSCOPIC APPENDECTOMY PROCEDURE, THE SUBJECT DEVICE HAD GREEN IMAGE AND ERROR E104: FOG-FREE FUNCTION WAS NOT WORKING. A SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1100625 VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE LAPAROSCOPE, GYNECOLOGIC HET OLYMPUS WINTER & IBE GMBH WA50042A 04042761074971

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown