BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMAGE1 S HX-P FI

    MDR report key: 19578652 · Received June 20, 2024

    Report

    Report Number
    9610617-2024-00183
    Event Type
    Malfunction
    Date Received
    June 20, 2024
    Date of Event
    May 30, 2024
    Report Date
    November 25, 2024
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    FET
    UDI-DI
    04048551407042
    PMA / PMN Number
    K160044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IS PROVIDED IN SECTION B5. THE INVESTIGATION IS NOT COMPLETED YET. THE INVESTIGATION RESULTS ARE PENDING. PLEASE NOTE THE CORRECTION IN THE MANUFACTURING SITE NUMBER FROM THE INITIAL REPORT WAS INCORRECT. THE INITIAL REPORT AS WELL AS THIS SUPPLEMENTAL REPORT SHOULD HAVE THE MANUFACTURING SITE NUMBER OF (B)(4) AND NOT (B)(4). THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    BECAUSE THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION, THE CAUSE CAN ONLY BE DETERMINED BASED ON PAST EXPERIENCE. THE MOST PROBABLE ROOT CAUSE IS THE TECHNIQUE OF THE CAMERA HEAD SENSOR (CMOS-SENSOR) USING A ROLLING SHUTTER. THE LASER UNIT, CAUSING THE INTERFERENCE, IS PRODUCING HIGH AMOUNT OF LIGHT WHICH THE ROLLING SHUTTER IS NOT ABLE TO COMPENSATE. THIS IS UNFORTUNATELY A TECHNICAL ISSUE WHICH CANNOT RESOLVED NOW TECHNICALLY. PLEASE NOTE THE CORRECTION IN THE MANUFACTURING SITE NUMBER FROM THE INITIAL REPORT WAS INCORRECT. THE INITIAL REPORT AS WELL AS THIS SUPPLEMENTAL REPORT SHOULD HAVE THE MANUFACTURING SITE NUMBER OF 2027009 AND NOT 9610617. INTERNAL KARL STORZ REFERENCE NUMBER.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    IT WAS DISCOVERED THAT ON THE SECOND SUPPLEMENTAL REPORT FOR THIS EVENT, SECTION B WAS INCORRECTLY LABELED AS A "DEATH". THIS CORRECTIVE REPORT IS TO MAKE CLEAR THAT THERE WERE NO DEATHS ASSOCIATED WITH THIS EVENT. PLEASE NOTE THE CORRECTION IN THE MANUFACTURING SITE NUMBER FROM THE INITIAL REPORT WAS INCORRECT. THE INITIAL REPORT AS WELL AS THIS SUPPLEMENTAL REPORT SHOULD HAVE THE MANUFACTURING SITE NUMBER OF 2027009 AND NOT 9610617. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    PLEASE DISREGARD THE THIRD SUPPLEMENTAL REPORT. IT WAS DISCOVERED THAT ON THE FIRST SUPPLEMENTAL REPORT FOR THIS EVENT, SECTION B WAS INCORRECTLY LABELED AS A "DEATH". THIS CORRECTIVE REPORT IS TO MAKE CLEAR THAT THERE WERE NO DEATHS ASSOCIATED WITH THIS EVENT. PLEASE NOTE THE CORRECTION IN THE MANUFACTURING SITE NUMBER FROM THE INITIAL REPORT WAS INCORRECT. THE INITIAL REPORT AS WELL AS THIS SUPPLEMENTAL REPORT SHOULD HAVE THE MANUFACTURING SITE NUMBER OF 2027009 AND NOT 9610617. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS PROVIDED THAT THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING MEDICAL PROCEDURE THERE WAS ISSUE WITH CAMERA IMAGE. THE CAMERA SUFFERS FROM INTERFERENCE THAT MAKES IT COMPLETELY UNUSABLE. PATIENT WAS UNDER ANESTHESIA. PROCEDURE WAS ABORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1577922 IMAGE1 S HX-P FI ENDOSCOPE VIDEO CAMERA FET KARL STORZ SE & CO. KG TH113 04048551407042

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| O