BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASM,HEAD,IMAGE1 S,H3-ZA, CE

    MDR report key: 22153264 · Received June 5, 2025

    Report

    Report Number
    2027009-2025-00979
    Event Type
    Malfunction
    Date Received
    June 5, 2025
    Report Date
    November 6, 2025
    Manufacturer
    KARL STORZ IMAGING
    Product Code
    FET
    UDI-DI
    04048551333969
    PMA / PMN Number
    K131953
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IN QUESTION WAS RETURNED TO MANUFACTURER. THIS INFORMATION IS REFLECTED IN SECTION D9. THE EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN. THE INVESTIGATION WILL BE PERFORMED BY A DESIGNATED KARL STORZ EMPLOYEE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    RESULT OF INVESTIGATION: DURING THE MANUFACTURER'S TECHNICAL INSPECTION, THE ERROR DESCRIBED BY THE CUSTOMER AS 'NO IMAGE' WAS CONFIRMED AND ASSIGNED TO A DEFECTIVE CAMERA HEAD CABLE. THE TH100 WAS FOUND TO HAVE A CABLE THAT WAS VISUALLY IN GOOD CONDITION. HOWEVER, IT DID NOT WORK AS EXPECTED. IT IS UNCLEAR WHETHER THE TH104 WORKED FOR A WHILE OR FAILED ON FIRST USE AFTER THE LAST REPAIR. THE CAUSE OF THE FAILURE WAS AN ELECTRICAL COMPONENT FAULT. ACCORDING TO THE IFU VISUAL AS WELL AS FUNCTIONALITY SHOULD ALWAYS BE CHECKED BEFORE EVERY USE TO AVOID INJURIES AND DAMAGES TO THE PRODUCT. FURTHERMORE, A SPARE DEVICE SHOULD BE AVAILABLE IN CASE THE DEVICE FAILS DURING USE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAS NO IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265695 ASM,HEAD,IMAGE1 S,H3-ZA, CE ASM,HEAD,IMAGE1 S,H3-ZA, CE FET KARL STORZ IMAGING TH104 04048551333969

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown