BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO-OPTIK "ENDOEYE 3D", 30°

    MDR report key: 19669744 · Received July 3, 2024

    Report

    Report Number
    9610773-2024-31506
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    June 21, 2024
    Report Date
    November 13, 2024
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GCM
    UDI-DI
    04042761083492
    PMA / PMN Number
    K193026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1 FACILITY ADDRESS: (B)(6). E2/E3: NO INFORMATION AVAILABLE FOR THE 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.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER. UPDATED FIELDS: B5; E2; E3; G2. 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 NOT CONFIRMED. IN ADDITION, THE FOLLOWING REPORTABLE MALFUNCTIONS WERE IDENTIFIED DURING THE DEVICE EVALUATION: E226 SCOPE COMMUNICATION ERROR AND UNIVERSAL CORD SHEATH MALFUNCTION. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE SCOPE COMMUNICATION ERROR WAS DUE TO THE UNIVERSAL CORD SHEATH MALFUNCTION. 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 THE SUBJECT DEVICE NOTICED AN ERROR "E216". THE ISSUE OCCURRED DURING PREPARATION PRIOR TO A THERAPEUTIC LAPAROSCOPY PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1132610 VIDEO-OPTIK "ENDOEYE 3D", 30° RIGID VIDEO LAPAROSCOPE GCM OLYMPUS WINTER & IBE GMBH WA50082A 04042761083492

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown OTV-S3006.