BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIPCAM 1 S 3D LAP, 0°

    MDR report key: 22482394 · Received July 11, 2025

    Report

    Report Number
    9610617-2025-01176
    Event Type
    Malfunction
    Date Received
    July 11, 2025
    Date of Event
    June 19, 2025
    Report Date
    March 16, 2026
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    FGB
    UDI-DI
    04048551347782
    PMA / PMN Number
    K150525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICES CONCERNED (TC302 - IMAGE1 S D3-LINK, SERIAL# (B)(6) AND 26605AA - TIPCAM 1 S 3D LAP, 0°, SERIAL# (B)(6)) WERE NOT RETURNED TO THE MANUFACTURER FOR INSPECTION. THEREFORE, A PHYSICAL TECHNICAL INSPECTION WAS NOT POSSIBLE, AND A PRECISE ERROR ANALYSIS COULD NOT BE CARRIED OUT. THE INVESTIGATION COULD ONLY BE PERFORMED BASED ON THE AVAILABLE EVENT INFORMATION, WHICH STATES THAT "DURING A ROBOTIC LAPAROSCOPIC RADICAL PROSTATECTOMY PROCEDURE, THE IMAGE WAS LOST MOMENTARILY, AS IF IT HAD RESTARTED. WHEN THE TEAM ATTEMPTED TO VIRTUALLY REVERSE THE IMAGE, THE ENDOSCOPE BUTTONS DID NOT RESPOND AND STOPPED FUNCTIONING. THE TEAM UNPLUGGED AND RECONNECTED THE COMMUNICATION CABLE OF THE ENDOSCOPE, WHICH RESTORED THE IMAGE. HOWEVER, THE ENDOSCOPE BUTTONS REMAINED NON-FUNCTIONAL. THE TEAM MANUALLY ROTATED THE CAMERA TO RESOLVE THE ISSUE. THIS RESULTED IN A 10-MINUTE DELAY. THERE WAS NO PATIENT INJURY." FURTHERMORE, THE CUSTOMER PROVIDED A PHOTO OF AN ERROR MESSAGE WHICH STATES THAT THERE WAS AN ENDOSCOPE FAILURE. BASED ON THE ERROR MESSAGE IT IS CONCLUDED THAT THE DEVICE TC302 WAS NOT CAUSATIVE, BECAUSE THE ERROR MESSAGE INDICATES AN ENDOSCOPE ERROR. AS STATED, A PRECISE ERROR ANALYSIS IS NOT POSSIBLE WITHOUT THE DEVICES AND ACCORDING TO THE EVENT INFORMATION IT IS POSSIBLE THAT THE 26605AA TIPCAM CAMERA WAS NOT PRIMARILY RESPONSIBLE FOR THE SYSTEM FAILURE, AS THE CAMERA, IN COMBINATION WITH A COMPUTER-CONTROLLED ROBOTIC ARM, FORMS A SYSTEM NETWORK THAT FAILED FOR REASONS WHICH ARE NOT KNOWN. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC RADICAL PROSTATECTOMY PROCEDURE, THE IMAGE WAS LOST MOMENTARILY, AS IF IT HAD RESTARTED. WHEN THE TEAM ATTEMPTED TO VIRTUALLY REVERSE THE IMAGE, THE ENDOSCOPE BUTTONS DID NOT RESPOND AND STOPPED FUNCTIONING. THE TEAM UNPLUGGED AND RECONNECTED THE COMMUNICATION CABLE OF THE ENDOSCOPE, WHICH RESTORED THE IMAGE. HOWEVER, THE ENDOSCOPE BUTTONS REMAINED NON-FUNCTIONAL. THE TEAM MANUALLY ROTATED THE CAMERA TO RESOLVE THE ISSUE. THIS RESULTED IN A 10-MINUTE DELAY. THERE WAS NO PATIENT INJURY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR: 9610617-2025-01175.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872937 TIPCAM 1 S 3D LAP, 0° TIPCAM 1 S 3D LAP, 0° FGB KARL STORZ SE & CO. KG 26605AA 04048551347782

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown