BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD CAMERA HEAD

    MDR report key: 18433368 · Received January 3, 2024

    Report

    Report Number
    3002808148-2024-30008
    Event Type
    Malfunction
    Date Received
    January 3, 2024
    Report Date
    April 4, 2025
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170336669
    PMA / PMN Number
    K102059
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    E2: NI. G1: MANUFACTURING CONTACT OFFICE FACILITY NAME: SHIRAKAWA OLYMPUS CO., LTD. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    UPDATE B5 THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE SUBJECT DEVICE WAS EVALUATED. DEVICE EVALUATION NOTED THE CUSTOMER REPORTED ISSUE WAS CONFIRMED. ADDITIONAL FINDINGS INCLUDE FLOODING OF THE MAIN BODY, CORROSION OF ELECTRICAL CONTACTS AT CONNECTORS, AND SCOPE MOUNT. MOREOVER, STRIKE MARKS ON ELECTRICAL CONTACTS AT THE CONNECTOR AND WEAR OF MAIN BODY NOTED. THE DEVICE HISTORY RECORDS (DHR¿S) FOR THIS PRODUCT HAVE BEEN REVIEWED. ALL RECORDS INDICATE THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. PER INSTRUCTION FOR USE (IFU), IT STATES, HANDLING AND GENERAL PRECAUTIONS (WARNING) THE ELECTRICAL CONTACTS OF THE VIDEO CONNECTOR AND THEIR SURROUNDINGS SHOULD BE WIPED DRY WITH DRY GAUZE AND CONNECTED TO THE VIDEO SYSTEM CENTER IN A SUFFICIENTLY DRY CONDITION. IN ADDITION, MAKE SURE THAT THE ELECTRICAL CONTACTS ARE FREE OF DIRT BEFORE CONNECTING THEM. USE OF THE EQUIPMENT WITH WET OR DIRTY ELECTRICAL CONTACTS MAY RESULT IN EQUIPMENT FAILURE OR ENDANGER THE SAFETY OF THE PATIENT OR SURGEON. (CAUTION) DO NOT APPLY IMPACT TO THE CAMERA HEAD. DOING SO MAY RESULT IN DAMAGE. DO NOT BUMP OR BEND THE ELECTRICAL CONTACTS OF THE VIDEO CONNECTOR. DOING SO MAY PREVENT CONNECTION TO THE VIDEO SYSTEM CENTER OR CAUSE A POOR CONNECTION." OLYMPUS WILL CONTINUE TO MONITOR COMPLAINTS ABOUT THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL EMDR IS BEING SUBMITTED TO CORRECT THE MANUFACTURING DATE: H4.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT THE DEVICE CONNECTOR SECTION WAS CRACKED. THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT.

    Description of Event or Problem · 0

    THIS REPORT IS BEING SUPPLEMENTED BASED ON THE INVESTIGATION COMPLETED BY THE MANUFACTURER.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491980 HD CAMERA HEAD AUTOCLAVABLE CAMERA HEAD FET SHIRAKAWA OLYMPUS CO., LTD. CH-S190-08-LB 04953170336669

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown