BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20385523 · Received October 7, 2024

    Report

    Report Number
    9610773-2024-32933
    Event Type
    Malfunction
    Date Received
    October 7, 2024
    Date of Event
    September 24, 2024
    Report Date
    October 25, 2024
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HET
    UDI-DI
    04042761074971
    PMA / PMN Number
    K190744
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTABLE MALFUNCTION WAS CONFIRMED. IN ADDITION, THE FOLLOWING REPORTABLE MALFUNCTIONS WERE FOUND DURING THE DEVICE EVALUATION: THE VIDEO CABLE IS BROKEN, THE FIBER BONDING IN THE OUTER TUBE AREA (DISTAL END) IS DAMAGED AND THE PROTECTOR OF THE VIDEO CABLE SECTION IS CUT. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. HOWEVER, BASED ON THE RESULTS OF THE INVESTIGATION, THE BROKEN VIDEO CABLE LIKELY LED TO THE STRIPES IN IMAGE TO OCCUR. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE BROKEN VIDEO CABLE, THE DAMAGED FIBER BONDING IN THE OUTER TUBE AREA (DISTAL END), AND THE PROTECTOR OF THE VIDEO CABLE SECTION BEING CUT. 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

    E2/E3: INFORMATION WAS ASKED BUT UNKNOWN, IN REGARD TO OCCUPATION OF THE INITIAL REPORTER OR WHETHER THEY ARE A HEALTHCARE PROFESSIONAL. 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

    IT WAS REPORTED THAT THE SUBJECT DEVICE EXPERIENCED IMAGE ERROR AND IMAGE INTERFERENCE. THE ISSUE OCCURRED DURING THE MINIMALLY INVASIVE THERAPEUTIC SURGERY PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT. THERE WERE NO REPORTS OF PATIENT HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SUBJECT DEVICE EXPERIENCED IMAGE ERROR AND IMAGE INTERFERENCE. THE ISSUE OCCURRED DURING THE MINIMALLY INVASIVE THERAPEUTIC SURGERY PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216773 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