BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPIC VIDEO IMAGING SYSTEM/COMPONENT, GASTROENTEROLOGY-UROLOGY

    MDR report key: 23943848 · Received January 2, 2026

    Report

    Report Number
    MW5181579
    Event Type
    Malfunction
    Date Received
    January 2, 2026
    Report Date
    November 10, 2025
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    FET
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TELE PACK X LED MONITOR IS WORN OUT AND CANNOT BE PROPERLY ADJUSTED. THE CURRENT WEAR CONDITION AFFECTS STABILITY AND POSITIONING, POTENTIALLY IMPACTING OPERATIONAL EFFICIENCY. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Description of Event or Problem · 0

    ADD'L INFO RECEIVED ON 01/29/2026 FOR REPORT MW5181579 TO CORRECT SPELLING OF THE MFR NAME TO KARL STORZ SE & CO. KG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13963 ENDOSCOPIC VIDEO IMAGING SYSTEM/COMPONENT, GASTROENTEROLOGY-UROLOGY ENDOSCOPIC VIDEO IMAGING SYSTEM/COMPONENT, GASTROENTEROLOGY-UROLOGY FET KARL STORZ SE & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other