BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPIC VIDEO IMAGING SYSTEM/COMPONENT, GASTROENTEROLOGY-UROLOGY

    MDR report key: 24471180 · Received February 27, 2026

    Report

    Report Number
    9610617-2026-00389
    Event Type
    Malfunction
    Date Received
    February 27, 2026
    Date of Event
    February 6, 2026
    Report Date
    May 27, 2026
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    FET
    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 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO A ROBOTIC LAPAROSCOPIC TRANSANAL MINIMALLY INVASIVE SURGERY, AN "ENDOSCOPE ERROR" ERROR WAS TRIGGERED. TO RESOLVE THE ISSUE, THE TEAM REBOOTED THE ICG AND CONNECTED AND DISCONNECTED THE CABLES ON THE BACK OF THE TC201EN MODULE (VIDEO OUTPUTS). NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157845 ENDOSCOPIC VIDEO IMAGING SYSTEM/COMPONENT, GASTROENTEROLOGY-UROLOGY FET KARL STORZ SE & CO. KG TC201EN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown