BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO TELESCOPE "ENDOEYE", 10 MM, 30°, PAL, HD COMPATIBLE, AUTOCLAVABLE

    MDR report key: 19856483 · Received July 29, 2024

    Report

    Report Number
    9610773-2024-31920
    Event Type
    Malfunction
    Date Received
    July 29, 2024
    Date of Event
    July 24, 2024
    Report Date
    December 6, 2024
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    NWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1 - FACILITY NAME: (B)(6) HOSPITAL, (B)(6) MEDICAL UNIVERSITY. E1 - ADDRESS 1: (B)(6). 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. UPDATED FIELDS: D8, G3, H2, H3, H4, H6, H11. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS CONFIRMED. IN ADDITION, THE FOLLOWING REPORTABLE MALFUNCTIONS WERE IDENTIFIED DURING THE DEVICE EVALUATION: UC SHEATH MALFUNCTION / COMPONENT FAILURE OF THE UC SHEATH. THE CAUSE OF THE UC SHEATH FAILURE COULD NOT BE DETERMINED. THE MOST LIKELY CAUSE IS THAT THE CABLE WAS DAMAGED BY THE FORCE OF BEING PULLED. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: COMPONENT FAILURE OF UC SHEATH CAUSES THE IMAGE TO BE BLURRED AND DISTORTED. 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 HAD BLURRED AND INDISTINCT IMAGE. THE ISSUE WAS FOUND DURING CLEANING AND DISINFECTION. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2483856 VIDEO TELESCOPE "ENDOEYE", 10 MM, 30°, PAL, HD COMPATIBLE, AUTOCLAVABLE RIGID VIDEO LAPAROSCOPE NWB OLYMPUS WINTER & IBE GMBH WA50012A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown