BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS XENON SHORT-ARC LAMP

    MDR report key: 3944301 · Received May 8, 2014

    Report

    Report Number
    8010047-2014-00196
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 9, 2014
    Report Date
    January 6, 2016
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GCT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) PERFORMED A MDR RETROSPECTIVE REVIEW AND FOUND THAT THIS SUPPLEMENTAL REPORT IS REQUIRED ON DECEMBER 11, 2015. THIS IS A SUPPLEMENTAL REPORT FOR MFR REPORT #8010047-2014-00196 TO PROVIDE DEVICE EVALUATION RESULTS. OLYMPUS PERFORMED AN ADDITIONAL INVESTIGATION OF THE SUBJECT DEVICE. BASED ON THE REPORT BY THE MAKER OF THE LAMP OF THE SUBJECT DEVICE, THERE WERE SOME PRODUCTS IN WHICH THE RESIDUAL STRESS EXISTED IN THE GLASS OF THE LAMP BECAUSE OF LOW ASSEMBLY ACCURACY IN THE PRODUCTION BEFORE MARCH, 2013. THE ASSEMBLY PROCESS WAS IMPROVED IN APRIL, 2013 SO THAT THE RESIDUAL STRESS WAS REMOVED. IT WAS FOUND THAT THE LAMP OF THE SUBJECT DEVICE WAS ASSEMBLED IN MARCH, 2012. SO THERE IS THE POSSIBILITY THAT THERE WAS A RESIDUAL STRESS IN THE LAMP GLASS USED IN THE SUBJECT DEVICE AND THE THERMAL STRESS GENERATED BY CYCLES OF ON AND OFF OF THE LAMP CAUSED THE CRACK OF THE GLASS. THE INSTRUCTION MANUAL OF THE LIGHT SOUSE USED WITH THE SUBJECT DEVICE ALREADY STATES; ANYTIME YOU OBSERVE AN IRREGULARITY IN A LIGHT SOURCE FUNCTION, STOP THE EXAMINATION IMMEDIATELY AND TAKE ACTION ACCORDING TO THE FOLLOWING PROCEDURES. USING A DEFECTIVE LIGHT SOURCE MAY CAUSE PATIENT AND/OR OPERATOR INJURY. AFTER WITHDRAWING THE ENDOSCOPE FROM THE PATIENT, REFER TO THE INSTRUCTIONS IN CHAPTER 8, "TROUBLESHOOTING". IF THE PROBLEM CANNOT BE RESOLVED BY THE REMEDIAL ACTION AS DESCRIBED IN CHAPTER 8, DO NOT USE THE LIGHT SOURCE AND IMMEDIATELY CONTACT OLYMPUS. -IF THE EXAMINATION LAMP FAILS AND THE EMERGENCY LAMP LIGHTS UP, TURN OFF THE LIGHT SOURCE, AND THEN LIGHT UP THE EXAMINATION LAMP AGAIN. IF THE EMERGENCY LAMP STILL LIGHTS UP, CONFIRM THE PATIENT'S SAFETY AND THEN CONNECT THE ENDOSCOPE TO A SPARE LIGHT SOURCE. NOTE THAT THE EMERGENCY LAMP OFFERS ONLY THE MINIMUM BRIGHTNESS REQUIRED IN CASE OF AN EMERGENCY AND IT IS DANGEROUS TO CONTINUE THE USE OF THE LIGHT SOURCE UNDER THE EMERGENCY LAMP. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP (OMSC) FOR EVALUATION. THE EVALUATION CONFIRMED THAT THERE WERE SCRATCHES AND CRACKS ON THE SURFACE GLASS OF THE MD-631. IT WOULD APPEAR THAT THESE DAMAGES CAUSED THE EXTINCTION OF THE LAMP. BASED ON THE SIMILAR CASES WITH THE SAME MODEL, IT IS KNOWN THAT BY INAPPROPRIATE HANDLING OF THE MD-631 SUCH AS THE ADHESION OF THE FOREIGN OBJECT ON THE SURFACE GLASS, STRONG IMPACT, AND/OR NOT SECURED INSTALLATION, THE MD-631 GETS BROKEN. THE MANUFACTURING HISTORY WAS REVIEWED WITH NO IRREGULARITIES NOTED. BASED ON THE FINDING OF THE EVALUATION, THIS REPORT APPEARS TO BE RELATED TO USER HANDLING. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING THE UNSPECIFIED LAPAROSCOPIC SURGERY, THE LAMP (MD-631) OF THE LIGHT SOURCE HAD GONE OUT AND THE SPARE LAMP HAD BEEN LIT. THE PHYSICIAN HAD COMPLETED THE PROCEDURE WITH USE OF THE OTHER LIGHT SOURCE. THERE WAS NO REPORT OF THE PATIENT'S INJURY REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278080 OLYMPUS XENON SHORT-ARC LAMP ENDOSCOPE AND ACCESSORIES GCT OLYMPUS MEDICAL SYSTEMS CORPORATION MD-631 NA

    Patients

    Seq Age Sex Outcome Treatment
    1