BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOCAM

    MDR report key: 17185875 · Received June 22, 2023

    Report

    Report Number
    9611102-2023-00038
    Event Type
    Malfunction
    Date Received
    June 22, 2023
    Date of Event
    May 19, 2023
    Report Date
    August 17, 2023
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    FET
    UDI-DI
    04055207063163
    PMA / PMN Number
    K180583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOGIC 4K CAMERA HEAD, PART ID: 85525942, SERIAL# (B)(6) WAS INVESTIGATED AT RICHARD WOLF GMBH. DURING INSPECTION IT WAS DETERMINED IN ACCORDANCE WITH TEST INSTRUCTIONS, THAT THE LOGIC 4K CAMERA HEAD SPORADICALLY HEATS UP EXCEPTIONALLY STRONG. IN ADDITION, THE REPORTED SUSPECT DEVICE WITH ATTACHED ZOOM LENS, PART ID. 85261504, SN(B)(6), WAS OPERATED ON A TEST EQUIPMENT, ENDOCAM LOGIC 4K CONTROLLER 5525301 SN(B)(6)FOR 7 DAYS, RECORDING THE SURFACE TEMPERATURE AT 7 SPECIFIED TEMPERATURE MEASUREMENT POINTS WITH THE DATA LOGGER. IN THE USER'S COMPLAINT REPORT, THE ERROR PATTERN IS "SPORADICALLY OCCURRING ERROR" (SURFACE TEMPERATURE TOO HIGH). FROM AN EXPERT'S POINT OF VIEW, THE DIFFERENT SURFACE TEMPERATURES CAN INDICATE A SPORADICALLY OCCURRING ERROR, HIGHER CURRENT CONSUMPTION AND THE ASSOCIATED POWER CONSUMPTION OF THE INSTALLED ELECTRONIC COMPONENTS WITHIN THE HERMETICALLY SEALED CAMERA HEAD. THE HEAT IS DISSIPATED VIA THE SURFACE OF THE HOUSING. WITH REGARD TO THE 2-HOUR OP TIME EXTENSION, WE SUSPECT A USER ERROR BECAUSE THE APPLICATION COULD HAVE BEEN CARRIED OUT PURELY OPTICALLY WITHOUT A CAMERA SYSTEM. FOR THIS, ONLY THE CAMERA HEAD WOULD HAVE HAD TO BE SEPARATED FROM THE OPTICS. THE LOGIC 4K CAMERA HEAD, PART ID. 85525942, SN NO. (B)(6) WAS MANUFACTURED ON 19/APR/2022. NO ISSUE WAS IDENTIFIED DURING PRODUCTION. THE SUBJECT LOGIC 4K CAMERA HEAD WAS DELIVERED TO THE CUSTOMER ON 15/JUN/2022. IN OCTOBER 2022, THE CAMERA HEAD WAS RETURNED TO RICHARD WOLF DUE TO THE SAME ERROR DESCRIPTION. AT THAT TIME OF INSPECTION, THE ERROR COULD NOT BE REPRODUCED. THE IFU BB-A282-05 /EN/ US I V2.0 / 2021-07 / PK21-0089 CONTAINS SEVERAL DESCRIPTIONS OF VISUAL AND FUNCTIONAL CHECKS WHICH SERVE TO DETECT FAULTS PRIOR TO USE ON PATIENT SECTION 4 INDICATIONS FOR USE AND SECTION 8 CHECKS. IN ADDITIONAL, THE IFU STATES THAT THERE MUST ALWAYS BE A SECOND PRODUCT WITH THE SAME FEATURES SHOULD BE AVAILABLE AS A BACKUP. IN THE CASE OF FAILURE OR INTERRUPTION OF THE SURGERY IMAGE OR INACCEPTABLE IMPAIRMENT OF THE REPRODUCTION QUALITY DURING THERAPEUTIC USE: DISCONNECT THE CAMERA FROM THE ENDOSCOPE AND VIEW THE OPERATING AREA DIRECTLY THROUGH THE EYEPIECE. THE SUBJECT ISSUE IS PRESENT IN THE RISK MANAGEMENT FILE E2-2 REV. 0001 - CAMERA HEAD. THE OVERALL PROBABILITY OF OCCURRENCE FOR THIS ISSUE IS CONSISTENT WITH PREVIOUSLY DEFINED LEVELS AND THE OVERALL RISK OF THE DEVICE REMAINS IN ACCEPTABLE CATEGORY.

    Additional Manufacturer Narrative · 0

    NO ISSUE WAS IDENTIFIED DURING PRODUCTION AND NO FURTHER COMPLAINTS WERE RECEIVED FROM PRODUCTION ORDER.

    Description of Event or Problem · 0

    A DISTRIBUTOR HAS INFORMED RICHARD WOLF GMBH AN ISSUE REGARDING A LOGIC 4K CAMERA HEAD C-MOUNT, PART ID: 85525942, SERIAL #: (B)(6). ACCORDING TO THE RECEIVED INFORMATION, IT WAS COMPLAINED THAT THE CAMERA HEAD HEATED UP SO MUCH THAT THE USER COULD NO LONGER HOLD IT IN HIS HAND. ALSO, IT WAS REPORTED THAT THIS EXTENDED THE OPERATING ROOM TIME BY 2 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133471 ENDOCAM LOGIC 4K CAMERA HEAD C-MOUNT FET RICHARD WOLF GMBH 85525942 04055207063163

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown