BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO-OPTIK "ENDOEYE 3D", 30°

    MDR report key: 19773363 · Received July 18, 2024

    Report

    Report Number
    9610773-2024-31777
    Event Type
    Malfunction
    Date Received
    July 18, 2024
    Report Date
    December 27, 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

    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 INVESTIGATION. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED ISSUE WAS CONFIRMED. THE ISSUE REPORTED WAS FOUND TO BE DUE TO WATER DROPLETS ARE ADHERING TO THE INSERTION TUBE. ADDITIONALLY, THE FOLLOWING REPORTABLE MALFUNCTIONS WERE IDENTIFIED DURING THE DEVICE EVALUATION: SURFACE OF THE INSERTION TUBE WAS SLIGHTLY SCRATCHED, CABLE OF THE UP BOARD WAS WORN-OUT. THE CAUSE OF A COMPONENT FAILURE OF THE INSERTION TUBE COULD NOT BE DETERMINED. THE MOST LIKELY CAUSE IS PHYSICAL DAMAGE DUE TO CONTACT WITH OTHER EQUIPMENT DURING REPROCESSING OR TRANSPORTATION OR STORAGE. THE CABLE OF THE BOARD WAS WORN-OUT. THIS EVENT IS CAUSED BY A COMPONENT FAILURE OF THE VIDEO CONNECTOR. THE CAUSE OF A COMPONENT FAILURE OF THE VIDEO CONNECTOR COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RIGID VIDEO SCOPE SHOWED MARKS RESEMBLING WATER STAINS ON THE SURFACE OF THE ENDOSCOPE. THE ISSUE WAS FOUND DURING THE ACCEPTANCE ON ARRIVAL, THE PROCEDURE WAS COMPLETED WITH A SUBSTITUTE DEVICE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1918224 VIDEO-OPTIK "ENDOEYE 3D", 30° RIGID VIDEO LAPAROSCOPE GCM OLYMPUS WINTER & IBE GMBH WA50082A 04042761083492

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown