BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 0°, AUTOCLAVABLE

    MDR report key: 23006613 · Received September 9, 2025

    Report

    Report Number
    9610773-2025-05697
    Event Type
    Malfunction
    Date Received
    September 9, 2025
    Date of Event
    August 28, 2025
    Report Date
    November 4, 2025
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HET
    UDI-DI
    04042761074964
    PMA / PMN Number
    K190744
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE AN UPDATE ON FIELD H4 AND DUE TO A CORRECTION REQUIRED. UPDATED FIELDS: H2, H4. CORRECTED FIELD: B5. H6, H11. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: COMPONENT FAILURE A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. 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

    THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: COMPONENT FAILURE 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

    CORRECTION IS BEING MADE TO PREVIOUSLY SUBMITTED G4 - PMA/510(K) #, WHICH WAS NOT LATE. THE CORRECT PMA/510(K) # IS K190744.

    Description of Event or Problem · 0

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID VIDEO LAPAROSCOPE PRESENTED FAILURE OF THE UNIVERSAL CORD, DAMAGE ON CHARGED COUPLED DEVICE (CCD), THE IMAGE HAS WHITE DOTS AND DUE TO A CUT ON UNIVERSAL CORD, WATER TIGHTNESS WAS LOST. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THAT THE SUBJECT DEVICE PRESENTED A FAILURE OF THE UNIVERSAL CORD, DAMAGE ON CHARGED COUPLED DEVICE (CCD) AND DUE TO A CUT ON UNIVERSAL CORD, WATER TIGHTNESS WAS LOST. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THAT THE SUBJECT DEVICE PRESENTED A FAILURE OF THE UNIVERSAL CORD, DAMAGE ON CHARGED COUPLED DEVICE (CCD) AND DUE TO A CUT ON UNIVERSAL CORD, WATER TIGHTNESS WAS LOST. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2840819 VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 0°, AUTOCLAVABLE RIGID VIDEO LAPAROSCOPE HET OLYMPUS WINTER & IBE GMBH WA50040A 04042761074964

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown