BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHARGING UNIT, FOR 11301DE/DF

    MDR report key: 25023326 · Received April 28, 2026

    Report

    Report Number
    9610617-2026-00962
    Event Type
    Malfunction
    Date Received
    April 28, 2026
    Date of Event
    April 13, 2026
    Report Date
    April 28, 2026
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    HIH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 THE LIGHT SOURCE CANNOT BE TURNED OFF AFTER AN ENDOSCOPY PROCEDURE. IT HAS OVERHEATED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231253 CHARGING UNIT, FOR 11301DE/DF CHARGING UNIT, FOR 11301DE/DF HIH KARL STORZ SE & CO. KG 11301DG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown