BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17962530 · Received October 18, 2023

    Report

    Report Number
    2027009-2023-00298
    Event Type
    Malfunction
    Date Received
    October 18, 2023
    Date of Event
    February 7, 2022
    Report Date
    September 23, 2024
    Manufacturer
    KARL STORZ IMAGING
    Product Code
    FET
    UDI-DI
    04048551333969
    PMA / PMN Number
    K131953
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PREVIOUS REPORTABILITY DECISION FOR THIS EVENT WAS REVERSED BASED ON A RETROSPECTIVE REVIEW. THE MAIN ISSUE CAUSES WERE DETERMINED AS CONTAMINATION ON THE CARD EDGE LEADING TO INTERMITTENT CONNECTIONS WITH THE CCU RECEPTACLE, CABLE WORN-OUT CARD EDGE, WORN CABLE, AND UNEVEN WEAR IN THE OPTICAL ASSEMBLY. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY: THE INITIAL MDR HAD THE CORRECT UDI NUMBER BUT THE FIRST DIGIT "0" WAS OMITTED. PLEASE SEE SECTION D4 OF THIS MDR FORM FOR THE UPDATED UDI NUMBER. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID:(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED LOSS OF IMAGE DURING PROCEDURES. PROCEDURES COULD BE COMPLETED IN THREE CASES, EITHER USING A BACKUP UNIT OR THE SAME DEVICE AND NO HARM OCCURRED TO THE PATIENTS, USERS OR THIRD PARTIES. IN ONE CASE, NO FURTHER INFORMATION REGARDING THE OUTCOME OF THE PROCEDURE COULD BE OBTAINED AFTER MULTIPLE REQUEST ATTEMPTS. HOWEVER, IT IS UNLIKELY THAT THIS WOULD CAUSE PATIENT INJURY OR DEATH AS FACILITIES ROUTINELY HAVE BACK UP VIDEO EQUIPMENT THAT COULD BE USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1631484 ASM,HEAD,IMAGE1 S,H3-ZA, CE HEAD, IMAGE FET KARL STORZ IMAGING TH104 04048551333969

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown