BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19447829 · Received June 3, 2024

    Report

    Report Number
    9610773-2024-30895
    Event Type
    Malfunction
    Date Received
    June 3, 2024
    Date of Event
    April 26, 2024
    Report Date
    December 24, 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
    JA
    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 AND DUE TO CORRECTIONS REQUIRED. UPDATED FIELDS: D8, H2,H3, H4, H6, H11. CORRECTED FIELDS: E1 - (B)(6) AND G4 - PMA/510(K)#: K190744. 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 CONFIRMED. IN ADDITION, THE FOLLOWING REPORTABLE MALFUNCTION WAS IDENTIFIED DURING THE DEVICE EVALUATION: INSERTION TUBE IS BROKEN. A ROOT CAUSE COULD NOT BE IDENTIFIED. FOR THE DISTAL END WAS LOOSE, BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: CAUSE TRACED TO COMPONENT FAILURE. FOR THE INSERTION TUBE IS BROKEN THE EVENT IS CAUSED BY A COMPONENT FAILURE OF INSERTION TUBE. THE CAUSE OF INSERTION TUBE FAILURE COULD NOT BE DETERMINED. THE MOST LIKELY CAUSE IS THAT TOO MUCH FORCE WAS APPLIED TO THE INSERTION TUBE. 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

    NO INFORMATION AVAILABLE FOR THE OCCUPATION OF THE INITIAL REPORTER OR WHETHER THEY ARE A HEALTHCARE PROFESSIONAL. THE DEVICE EVALUATION 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

    NO ADDITIONAL INFORMATION FROM THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THE DISTAL END ON THE RIGID VIDEO LAPAROSCOPE WAS LOOSE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611417 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