BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOCAM

    MDR report key: 24626844 · Received March 18, 2026

    Report

    Report Number
    9611102-2026-00007
    Event Type
    Malfunction
    Date Received
    March 18, 2026
    Date of Event
    March 3, 2026
    Report Date
    March 18, 2026
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    FET
    UDI-DI
    04055207063163
    PMA / PMN Number
    K180583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE USER REPORTS THAT THE SURGERY TOOK LONGER THAN EXPECTED WHILE PATIENT WAS UNDER SEDATION. IN RICHARD WOLF GMBH RISK ANALYSIS E2 REV. R01, MANUFACTURING, HANDLING, AND DESIGN-RELATED HAZARDS REGARDING FUNCTIONAL IMPAIRMENTS, AS WELL AS RISKS ARISING FROM A NON-FUNCTIONAL PRODUCT AND RESULTING DELAYS IN SURGERY TIME, WERE CONSIDERED IN LIGHT OF THE CORRESPONDING SEVERITY OF HARM AND THE ASSUMED PROBABILITY OF OCCURRENCE AND ASSESSED AS AN ACCEPTABLE RISK. IN ADDITION, CHAPTER 8 OF THE INSTRUCTIONS FOR USE BB-A282-05 / EN / US / V2.0 / 2021-07 / PK21-0089 INSTRUCTS THE USER TO PERFORM A VISUAL AND FUNCTIONAL INSPECTION BEFORE AND AFTER EACH USE. AMONG OTHER THINGS, A FUNCTIONAL TEST MUST BE PERFORMED USING THE CORRESPONDING CAMERA CONTROLLER, WHEREBY A CLEAR LIVE IMAGE MUST BE VISIBLE ON THE MONITOR AFTER CONNECTING THE CAMERA HEAD. POTENTIAL FUNCTIONAL IMPAIRMENTS OF THE TYPE DESCRIBED ABOVE CAN BE EASILY DETECTED IF THESE INSTRUCTIONS ARE FOLLOWED. FURTHERMORE, USERS ARE ADVISED IN CHAPTERS 2 AND 4.3 THAT A FUNCTIONAL, EQUIVALENT SYSTEM SHOULD ALWAYS BE AVAILABLE DUE TO POTENTIAL FAILURES. A SEARCH OF THE RICHARD WOLF MDR DATABASE OVER THE PAST TWO YEARS REVEALED NO PREVIOUS REPORTS OF A SIMILAR ISSUE CLASSIFIED AS A REPORTABLE EVENT RESULTING IN DEATH OR SERIOUS INJURY. BASED ON THE INFORMATION AVAILABLE AND THE FACT THAT A 30-MINUTE DELAY OCCURRED, RW GMBH CONSIDER THIS CASE TO BE A REPORTABLE MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A HYSTEROSCOPY PROCEDURE, THE INSTRUMENT, ENDOCAM LOGIC 4K CAMERA HEAD, WAS NOT BEING DETECTED BY THE 4K MEDICAL/VIDEO MONITOR AND FAILED TO DISPLAY A LIVE IMAGE. A 30 MINUTE DELAY OCCURRED WHILE THE STAFF TRIED TO TROUBLESHOOT BUT NONE HAVE RESOLVED THE ISSUE. ANOTHER ENDOCAM CAMERA HEAD WAS ATTAINED AND WAS ABLE TO COMPLETE THE PROCEDURE. THERE IS NO REPORT OF INJURY TO THE PATIENT OR OTHER PERSONNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692164 ENDOCAM LOGIC 4K CAMERA HEAD C-MOUNT FET RICHARD WOLF GMBH 85525942 04055207063163

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown