BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EYEMAG LIGHT II

    MDR report key: 13476984 · Received February 7, 2022

    Report

    Report Number
    9615010-2022-00001
    Event Type
    Malfunction
    Date Received
    February 7, 2022
    Date of Event
    January 15, 2022
    Report Date
    April 4, 2022
    Manufacturer
    CARL ZEISS MEDITEC AG (OBERKOCHEN)
    Product Code
    KYT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZEISS IS THE CURRENT LEGAL MANUFACTURER FOR THE DEVICE EYEMAG LIGHT II. HOWEVER, THE AFFECTED EYEMAG LIGHT II WAS MANUFACTURED BY THE COMPANY SCHOTT AT LEAST 2 YEARS AGO, BEFORE ZEISS BECAME THE LEGAL MANUFACTURER.

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: THE AFFECTED DEVICE WAS FROM THE OLD BATCH (MANUFACTURED IN 2013 TO 2016). THE BATTERY HAS BEEN CHANGED WITH A 0V CHARGING PROTECTION SINCE 2017, THEREFORE NO CORRECTIVE ACTION IS REQUIRED FOR THE CURRENT MANUFACTURING PRODUCT. FOR THE BATTERY MANUFACTURED IN 2013 TO 2016, THE WORST CASE OF DEEP DISCHARGE WAS SIMULATED, WHICH DIDN'T INDICATE ANY SAFETY RISK IN THE PRACTICAL USAGE. THIS ISSUE IS A SINGLE CASE AND HAVE NO SIGN OF SIGNIFICANT OCCURRENCE. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A POTENTIAL QUALITY ISSUE WITH RESPECT TO CURRENT MANUFACTURING, DESIGN OR LABELING. FOLLOWING THE RISK-BASED APPROACH, NO FURTHER CORRECTIVE ACTION IS REQUIRED. CORRECTED DATA: H3: DEVICE EVALUATED BY MANUFACTURER? CHANGED FROM NO, TO YES. EVALUATION SUMMARY ATTACHED. H6: TYPE OF INVESTIGATION: ADDED 10, TESTING OF ACTUAL/SUSPECTED DEVICE; 11, TESTING OF DEVICE FROM SAME LOT/BATCH RETAINED BY MANUFACTURER; 4113, DEVICE NOT MANUFACTURED BY REPORTING MANUFACTURER; INVESTIGATION FINDINGS: CHANGED FROM 3233 (RESULTS PENDING COMPLETION OF INVESTIGATION) TO 135, DEGRADATION PROBLEM IDENTIFIED; 3227, POWER SOURCE PROBLEM IDENTIFIED; 4216, OVERHEATING PROBLEM IDENTIFIED; INVESTIGATION CONCLUSIONS: CHANGED FROM 11 (CONCLUSION NOT YET AVAILABLE) TO 18, FAILURE TO FOLLOW INSTRUCTIONS; 4301, DESIGN INADEQUATE FOR PURPOSE; H10: ADDED MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT HE REACTIVATED THE EYEMAG LIGHT II BY CHARGING THE BATTERY. THE EYEMAG LIGHT II HASN'T BEEN USED FOR ALMOST TWO YEARS. THE FIRST BATTERY CHARGED WITHOUT ANY ISSUES, BUT THE SECOND BATTERY RELEASED SMOKE WITH FIRE AFTER ABOUT FOUR HOURS OF CHARGING. THERE WAS NO ADVERSE IMPACT TO ANYONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1134568 EYEMAG LIGHT II LIGHT, EXAMINATION, MEDICAL, BATTERY POWERED KYT CARL ZEISS MEDITEC AG (OBERKOCHEN)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown