BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO TELESCOPE "ENDOEYE HD II", 5.4 MM, 30°, AUTOCLAVABLE

    MDR report key: 19827308 · Received July 25, 2024

    Report

    Report Number
    9610773-2024-31874
    Event Type
    Malfunction
    Date Received
    July 25, 2024
    Date of Event
    July 16, 2024
    Report Date
    September 11, 2024
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HET
    UDI-DI
    04042761075015
    PMA / PMN Number
    K190744
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 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 FOR EVALUATION AND THE CUSTOMER'S ALLEGATION WAS CONFIRMED. IN ADDITION, THE FOLLOWING REPORTABLE MALFUNCTIONS WERE IDENTIFIED DURING THE DEVICE EVALUATION: DENTS ON DISTAL EDGE AND CRACKS ON THE SIDE OF THE VIDEO CONNECTOR. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION OF NO IMAGE: CAUSE TRACED TO COMPONENT FAILURE, DUE TO DEGRADATION. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE DENTS ON DISTAL EDGE AND CRACKS ON THE SIDE OF THE VIDEO CONNECTOR. OLYMPUS WILL CONTINUE TO MONITOR THE PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RIGID VIDEOSCOPE HAD NO IMAGE. THERE WERE NO REPORTS OF PATIENT HARM. -------------------------------------------------------- -DENTS ON DISTAL EDGE. -DENTED OUTER TUBE. -LOOSE HANDLE. -LOOSE ADAPTER. -CRACKED ON SIDE. -CONFIRMED UR OF NO IMAGE 21/19. THIS NEW INFORMATION WAS TAKEN FROM A QUALITY INSPECTION REPORT (QIR) IN THE ACTION AC-026637. JR/496046/19-JUL-2024. ------------------------------------------------------- THE CUSTOMER FIRST AND LAST NAME FIELD WAS UPDATED ACCORDING TO THE INFORMATION RECEIVED FROM THE CUSTOMER'S AUTOMATIC RESPONSE. JR/ 496046/ 23-JUL-2024.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RIGID VIDEOSCOPE HAD NO IMAGE. THERE WERE NO REPORTS OF PATIENT HARM. -DENTS ON DISTAL EDGE. -DENTED OUTER TUBE. -LOOSE HANDLE. -LOOSE ADAPTER. -CRACKED ON SIDE. -CONFIRMED UR OF NO IMAGE (B)(6). THIS NEW INFORMATION WAS TAKEN FROM A QUALITY INSPECTION REPORT (QIR) IN THE ACTION (B)(4). JR/496046/(B)(6)2024. THE CUSTOMER FIRST AND LAST NAME FIELD WAS UPDATED ACCORDING TO THE INFORMATION RECEIVED FROM THE CUSTOMER'S AUTOMATIC RESPONSE. JR/ 496046/ (B)(6)2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350175 VIDEO TELESCOPE "ENDOEYE HD II", 5.4 MM, 30°, AUTOCLAVABLE RIGID VIDEO LAPAROSCOPE HET OLYMPUS WINTER & IBE GMBH WA50052A 04042761075015

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown