BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA ELITE XENON LIGHT SOURCE

    MDR report key: 18947603 · Received March 21, 2024

    Report

    Report Number
    3002808148-2024-02649
    Event Type
    Malfunction
    Date Received
    March 21, 2024
    Report Date
    April 11, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    NWB
    UDI-DI
    04953170301995
    PMA / PMN Number
    K111425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE DEVICE EVALUATION AND THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. CORRECTED FIELDS: G3 (THE AWARE DATE SHOULD BE 12-MARCH-2024 IN THE INITIAL MEDWATCH) H4 (SHOULD BE JULY 28, 2015, IN THE INITIAL MEDWATCH) H10 OF THE INITIAL REPORT DUE TO AN INADVERTENT ERROR: IT WAS STATED THAT ¿F24094860-1 :2024/03/13 EVENT PAE, TIER, UFC (USER REQUEST AND TER) EVENT 1. THE LENS EXPLODES DUE TO EXCESS HEAT. (IT HAS A BROKEN LENS.) PAE YES, TIER 2, CVP1336C EVENT 2. THE XENON LAMP IS BLOWN.: THE THERMAL PASTE APPLIED IS INSUFFICIENT FOR GOOD HEAT DISSIPATION. PAE YES, TIER 2, CVP2012A EVENT, PAE, TIER, UFC (TER) EVENT 3. THE LAMP ATTACHED TO THE CLV-S190 UNIT IS NOT ORIGINAL FROM OLYMPUS. PAE NO, TIER 3, CVV EVENT 4. THE METAL GRATE WAS BROKEN. PAE NO, TIER 3, CVP4601Y EVALUATION DATE: 2024/03/13 EVALUATOR: HIROYUKI SEKINE [FACTORY INVESTIGATION OF THE FOLLOWING EVENTS IS REQUIRED, IN THE FOLLOWING ORDER: EVENT NO., EVENT DESCRIPTION, PAE DETERMINATION, TIER, UFC]. (USER REQUEST AND TER) EVENT 1. THE LENS EXPLODES DUE TO EXCESS HEAT. (IT HAS A BROKEN LENS.) PAE YES, TIER 2, CVP1336C EVENT 2. THE XENON LAMP IS BLOWN.: THE THERMAL PASTE APPLIED IS INSUFFICIENT FOR GOOD HEAT DISSIPATION. PAE YES, TIER 2, CVP2012A [FACTORY INVESTIGATION OF THE FOLLOWING EVENTS IS NOT REQUIRED, IN THE FOLLOWING ORDER: EVENT NO., EVENT DESCRIPTION, PAE DETERMINATION, TIER, UFC]. (TER) EVENT 3. THE LAMP ATTACHED TO THE CLV-S190 UNIT IS NOT ORIGINAL FROM OLYMPUS. PAE NO, TIER 3, CVV EVENT 4. THE METAL GRATE WAS BROKEN. PAE NO, TIER 3, CVP4601Y CONTAINMENT MEASURES: NO (CURRENTLY, NO FACTS HAVE BEEN CONFIRMED THAT SUGGEST THE POSSIBILITY OF THE REPORTED EVENT EXPANDING.)¿. SHOULD BE ¿THE DEVICE EVALUATION IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.¿ DURING THE DEVICE INSPECTION, IT WAS OBSERVED THAT THE LAMP BEING USED WAS NOT AN OLYMPUS LAMP AND THE THERMAL PASTE APPLIED WAS NOT SUFFICIENT FOR GOOD HEAT DISSIPATION. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, IT IS LIKELY THAT EACH PART WAS DAMAGED DUE TO EXCESSIVE HEAT CAUSED BY THE USE OF NON-OLYMPUS LAMPS AND INCORRECT APPLICATION OF THERMAL PASTE. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: "ACCORDING TO THE INSTRUCTION MANUAL (RA6609) 6.1 REPLACEMENT OF THE EXAMINATION (XENON) LAMP NEVER INSTALL A LAMP THAT HAS NOT BEEN APPROVED BY OLYMPUS. THE USE OF A NONAPPROVED LAMP CAN CAUSE DAMAGE TO THE LIGHT SOURCE AND ANCILLARY EQUIPMENT, MALFUNCTION OR A FIRE. 6.3 INSERTION OF THE LAMP APPLY ENOUGH HEAT COMPOUND. IF NOT, ENOUGH HEAT COMPOUND IS APPLIED, THE HEAT CAN CAUSE LAMP IGNITION FAILURES." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    F24094860-1 : :2024/03/13. (USER REQUEST AND TER) EVENT 1. THE LENS EXPLODES DUE TO EXCESS HEAT. (IT HAS A BROKEN LENS.) PAE YES, TIER 2, CVP1336C. EVENT 2. THE XENON LAMP IS BLOWN.: THE THERMAL PASTE APPLIED IS INSUFFICIENT FOR GOOD HEAT DISSIPATION. PAE YES, TIER 2, CVP2012A. (TER) EVENT 3. THE LAMP ATTACHED TO THE CLV-S190 UNIT IS NOT ORIGINAL FROM OLYMPUS. PAE NO, TIER 3, CVV. EVENT 4. THE METAL GRATE WAS BROKEN. PAE NO, TIER 3, CVP4601Y. EVALUATION DATE: (B)(6) 2024. EVALUATOR: (B)(6). [FACTORY INVESTIGATION OF THE FOLLOWING EVENTS IS REQUIRED, IN THE FOLLOWING ORDER: EVENT NO., EVENT DESCRIPTION, PAE DETERMINATION, TIER, UFC]. (USER REQUEST AND TER) EVENT 1. THE LENS EXPLODES DUE TO EXCESS HEAT. (IT HAS A BROKEN LENS.) PAE YES, TIER 2, CVP1336C. EVENT 2. THE XENON LAMP IS BLOWN.: THE THERMAL PASTE APPLIED IS INSUFFICIENT FOR GOOD HEAT DISSIPATION. PAE YES, TIER 2, CVP2012A. [FACTORY INVESTIGATION OF THE FOLLOWING EVENTS IS NOT REQUIRED, IN THE FOLLOWING ORDER: EVENT NO., EVENT DESCRIPTION, PAE DETERMINATION, TIER, UFC]. (TER) EVENT 3. THE LAMP ATTACHED TO THE CLV-S190 UNIT IS NOT ORIGINAL FROM OLYMPUS. PAE NO, TIER 3, CVV. EVENT 4. THE METAL GRATE WAS BROKEN. PAE NO, TIER 3, CVP4601Y. CONTAINMENT MEASURES: NO (CURRENTLY, NO FACTS HAVE BEEN CONFIRMED THAT SUGGEST THE POSSIBILITY OF THE REPORTED EVENT EXPANDING.)

    Description of Event or Problem · 0

    IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE XENON LIGHT SOURCE EXHIBITED BROKEN LENS AND THE XENON LAMP BURST. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1756139 VISERA ELITE XENON LIGHT SOURCE XENON LIGHT SOURCE NWB SHIRAKAWA OLYMPUS CO., LTD. CLV-S190 04953170301995

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown