BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CCU,MODULAR,IMAGE1S 4U, CONNECT, INTL,CE

    MDR report key: 24476257 · Received February 27, 2026

    Report

    Report Number
    9610617-2026-00403
    Event Type
    Injury
    Date Received
    February 27, 2026
    Date of Event
    February 11, 2026
    Report Date
    March 10, 2026
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    FET
    PMA / PMN Number
    K160044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. DEVICE WAS NOT RETURNED AT THE TIME OF MDR SUBMISSION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    D.10 ADDITIONAL DEVICE INVOLVED. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION ADDED IN SECTION B5. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTION TO SECTION D10. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4) AND (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROBLEM OCCURRED DURING A SENTINEL NODE PROCEDURE, WHERE A RUBINA LENS, NIR/ICG EXOSKOP 90°, TH020 WAS MOUNTED ON THE CAMERA HEAD. DURING THE PROCEDURE, THE WERE COMMUNICATION PROBLEM BETWEEN THE VIDEO PROCESSOR AND THE RUBINA LIGHT SOURCE. THIS CONNECTION IS NECESSARY TO OPERATE THE ICG FUNCTION (OPAL). THIS FUNCTION WAS GRAYED OUT AND THEREFORE UNAVAILABLE. THEY RETRIEVED A COMPLETE SET FROM ANOTHER OR BECAUSE MOVING THE PATIENT WASN'T AN OPTION. THIS SET HAD THE EXACT SAME PROBLEM THE NETWORK CONNECTION WAS DOWN. TO SOLVE THIS PROBLEM TOOK TOO LONG, AND THE SURGEON DECIDED TO PROCEED WITHOUT AN ICG. A TYPE OF BLUE INK WAS USED TO ALLOW THE PROCEDURE TO PROCEED. THIS "INK" HAS REMAINED IN THE PATIENT FOR SEVERAL YEARS, WHICH IS UNDESIRABLE. APPARENTLY, THERE WAS SOMETHING WRONG WITH THE TIME DISPLAY IN BOTH THE VIDEO PROCESSOR AND THE LIGHT SOURCE. THEY HAD TO LOG IN TO BOTH DEVICES TO SYNCHRONIZE THEM. THE EVENT IS RELATED TO CASE (B)(4). DUE TO THIS UNPLANNED USING OF THE INK AND THE REMAINING IN PATIENTS BODY THE CASE IS DEEMED REPORTABLE.

    Description of Event or Problem · 0

    CROSS REFERENCE MDR: 9610617-2026-00401.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533001 CCU,MODULAR,IMAGE1S 4U, CONNECT, INTL,CE CCU,MODULAR,IMAGE1S 4U, CONNECT, INTL,CE FET KARL STORZ SE & CO. KG TC201

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other TC304 - IMAGE1 S 4U-LINK| TH020 - RUBINA LENS, NIR/ICG EXOSCOPE 90°| TH121 - IMAGE1 S 4U RUBINA, OPAL1 NIR/ICG| TL400 - POWER LED RUBINA, OPAL1 NIR/ICG