BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOCAM

    MDR report key: 17280831 · Received July 7, 2023

    Report

    Report Number
    9611102-2023-00046
    Event Type
    Malfunction
    Date Received
    July 7, 2023
    Date of Event
    April 26, 2023
    Report Date
    September 12, 2023
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    FET
    UDI-DI
    04055207063286
    PMA / PMN Number
    K200617
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    LOGIC 4K CAMERA CONTROLLER, PART ID 5525301, SERIAL #(B)(6) WAS MANUFACTURED ON 04/FEB/2022. THE BATCH CONSISTED OF 20 PIECES. NO ISSUE WAS IDENTIFIED DURING PRODUCTION AND NO FURTHER COMPLAINTS WERE RECEIVED FROM THE REPORTED BATCH.

    Additional Manufacturer Narrative · 0

    NEW INFORMATION: B4, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS), H7, AND H10. THE LOGIC 4K CAMERA CONTROLLER, PART ID: (B)(4), SERIAL # (B)(6) WAS INVESTIGATED AT RWGMBH. DURING THE INSPECTION OF THE CAMERA CONTROLLER, ACCORDING TO TEST INSTRUCTION PA01-001-9111, THE CUSTOMER COMPLAINT COULD NOT BE REPRODUCED DESPITE A TEST RUN OF 3 WEEKS. AFTER PRODUCTION, THE LOGIC 4K CAMERA CONTROLLERS ARE CHECKED FOR THEIR ELECTRICAL PARAMETERS IN ACCORDANCE WITH OUR TEST INSTRUCTION PA01-001-9111 AND SUBJECTED TO A FUNCTIONAL TEST. THESE TEST STEPS ENSURE THAT NO PRODUCTS ARE DELIVERED THAT HAVE NOT MET THEIR SPECIFICATIONS.THE SERVICE LIFE OF THE CONTROLLER AT THE CUSTOMER'S IS APPROX. 15 MONTHS. DURING THIS TIME, IT FUNCTIONED FAULTLESSLY AND HAS NOT YET BEEN REPAIRED AT RICHARD WOLF. AFTER A PERIOD OF USE OF APPROX. 15 MONTHS, THE CAUSE IS ASSESSED AS NOT TRACEABLE AFTER SEVERAL WEEKS OF TESTING. THE PRESENT LOGIC 4K CAMERA CONTROLLER OF THE TYPE 5525301 WITH THE SERIAL NUMBER (B)(6) ORIGINATES FROM THE PRODUCTION ORDER (B)(4), WHICH WAS BOOKED TO THE NEW GOODS WAREHOUSE ON 04/FEB/2022 WITH AN ORDER SIZE OF (B)(4) PIECES. A REVIEW OF THE RELEVANT PRODUCTION RECORDS DID NOT SHOW ANY RETURN DELIVERIES OR SPECIAL RELEASES WITHIN THE PRODUCTION LOT. NO COMPARABLE CASE HAS BEEN REGISTERED FOR THIS TYPE IN THE PERIOD UNDER CONSIDERATION. BASED ON THE AVAILABLE EVALUATION INFORMATION, THERE IS NO DIRECT RISK TO THE PATIENT, USER OR THIRD PARTIES. IN GENERAL, THE USER IS ADVISED IN THE ASSOCIATED INSTRUCTIONS FOR USE GA-A282 / EN / INT / V2.0 / 2021-08 / PK20-0139 UNDER CHAPTER 9 THAT A VISUAL AND FUNCTIONAL CHECK MUST BE CARRIED OUT BEFORE AND AFTER EACH USE. POSSIBLE FUNCTIONAL IMPAIRMENTS OF THE ABOVE TYPE CAN BE EASILY DETECTED BY HOSPITAL STAFF IF THESE INSTRUCTIONS ARE FOLLOWED. CHAPTER 5 ALSO POINTS OUT THAT A SECOND, EQUIVALENT CAMERA SHOULD BE AVAILABLE IN CASE OF A POSSIBLE DEVICE FAILURE DURING THERAPEUTIC USE. IN THE RISK ASSESSMENT E2-1, REV.04, HANDLING-RELATED, DESIGN-RELATED, AND MANUFACTURING-RELATED RISKS WITH REGARD TO IMPAIRED PHYSICAL PROPERTIES, SUCH AS IMAGE RESTRICTION, FUNCTIONAL RESTRICTION AS WELL AS HAZARDS DUE TO AN UNUSABLE PRODUCT WITH THE CORRESPONDING EXTENT OF DAMAGE AND THE ASSUMED PROBABILITY OF OCCURRENCE WERE CONSIDERED AND ASSESSED WITH AN ACCEPTABLE RISK.

    Description of Event or Problem · 0

    A USER FACILITY HAS INFORMED RICHARD WOLF GMBH AN ISSUE REGARDING A LOGIC 4K CAMERA CONTROLLER, PART ID: 5525301, SERIAL # (B)(6). ACCORDING TO THE RECEIVED INFORMATION, AT THE BEGINNING OF A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE, THE VIDEO PROCESSOR WAS SWITCHED ON. THE OPTICS WERE ALREADY IN THE PATIENT'S URETHRA. AFTER COMPLETION OF THE VIDEO PROCESSOR'S SELF-TEST, A LARGE YELLOW BANNER WAS DISPLAYED ON THE MONITOR: "THE DEVICE MAY HAVE LIMITED FUNCTIONALITY. NOTIFY SERVICE! ERROR..." ALTHOUGH THE CAMERA DISPLAYED AN IMAGE ON THE MONITOR, IT WAS ALMOST COMPLETELY OBSCURED BY THE ERROR MESSAGE. CONFIRMATION / ACKNOWLEDGEMENT WAS NOT POSSIBLE, SO THE APPLICATION HAD TO BE INTERRUPTED AND A REPLACEMENT DEVICE HAD TO BE INTEGRATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640220 ENDOCAM LOGIC 4K CAMERA CONTROLLER FET RICHARD WOLF GMBH 5525301 04055207063286

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other