BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MLX 300W XENON LIGHTSOURCE

    MDR report key: 10278026 · Received July 15, 2020

    Report

    Report Number
    2523190-2020-00017
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Date of Event
    February 5, 2020
    Report Date
    February 5, 2020
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    FCW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. FAILURE ANALYSIS CANNOT BE COMPLETED DUE TO THE LACK OF INFORMATION RECEIVED TO PERFORM A COMPLETE INVESTIGATION. THEREFORE, ROOT CAUSE ANALYSIS CANNOT BE COMPLETED AT THE MOMENT. NO FURTHER INVESTIGATION REQUIRED BASED ON THE ACCEPTABILITY OF RISK AND NO ADVERSE TRENDS IDENTIFIED. THIS WILL BE MONITORED AND TRENDED GOING FORWARD BETWEEN 05NOV2019 AND 30JUN2020, APPROXIMATELY 2,200 MDRS SUBMITTED ELECTRONICALLY BY INTEGRA LIFESCIENCES VIA TRACKWISE, INTEGRA'S COMPLAINT HANDLING SYSTEM, WERE NOT RECEIVED BY CDRH DUE TO A COMPUTER SYSTEM ISSUE. WITHIN THIS TIME PERIOD, AN ERROR WITH INTEGRA'S MIDDLEWARE, WHICH FACILITATES COMMUNICATIONS BETWEEN TRACKWISE AND THE FDA SYSTEM, CAUSED THE COMPLAINT RECORDS TO CLOSE AND INDICATE WE HAD RECEIVED AN ACKNOWLEDGEMENT 3 FROM THE FDA WHEN WE HAD NOT. INTEGRA INTERPRETED THE ACKNOWLEDGEMENT AS A SUCCESSFUL SUBMISSION; HOWEVER, SUBSEQUENT INVESTIGATION REVEALED THE ACKNOWLEDGEMENT 3 RECEIVED WAS FROM OUR MIDDLEWARE AND NOT FROM THE FDA (THESE ACKNOWLEDGEMENTS HAVE BEEN RETAINED AS PART OF THE DOCUMENTATION OF THE MDR). THE MALFUNCTION WAS RELATED TO THE RELOCATION OF THE TRACKWISE APPLICATION TO A NEW DATA CENTER DURING THE TRANSITION OF INTEGRA'S CORPORATE HEADQUARTERS FROM PLAINSBORO, NJ TO PRINCETON, NJ. PREVIOUSLY, INTEGRA HAD BEEN SUCCESSFULLY RECEIVING ACKNOWLEDGEMENTS 1, 2, AND 3 FROM THE FDA, AND OUR RECORDS REFLECT THESE ACKNOWLEDGEMENTS, INCLUDING THE DATE AND TIME STAMPS. CAPA PR 229048 AND NC 20-011 HAVE BEEN OPENED BY INTEGRA TO FURTHER INVESTIGATE THE NONCONFORMANCE AND DEVELOP A CORRECTIVE ACTION PLAN. THE MIDDLEWARE ERROR HAS BEEN CORRECTED, AND INTEGRA HAS FILED MDRS SINCE THE CORRECTION AND VERIFIED THAT THE APPROPRIATE ACKNOWLEDGEMENTS HAVE BEEN RECEIVED FROM THE FDA. INTEGRA IS RESUBMITTING ALL IMPACTED MDR REPORTS FOR THE TIME PERIOD 05NOV2019 THROUGH 30JUN2020. INTEGRA LIFESCIENCES CONTACTED (B)(4), DIRECTOR OF REGULATORY PROGRAMS, OFFICE OF PRODUCT EVALUATION AND QUALITY AND (B)(4), ASSISTANT DIRECTOR, MDR TEAM, OFFICE OF PRODUCT EVALUATION AND QUALITY ON JULY 8-9, 2020 TO REPORT THESE ISSUES REGARDING MDR REPORTS.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT YET RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. LINKED TO MFG REPORT NO.: 2523190-2020-00018.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2020, THE CABLE OF MLX 300W XENON LIGHTSOURCE BETWEEN THE HEADLIGHT AND THE UNIT OVERHEATED AND GLASS EXPLODED. THE CABLE WAS TOO HOT TO HANDLE AND THE TIP SHATTERED. ADDITIONAL INFORMATION RECEIVED ON 06FEB2020. INDICATED THAT THERE WAS A 20-MINUTE DELAY IN PROCEDURE WITH NO PATIENT INJURY. THE PRODUCT PROBLEM WAS DISCOVERED IMMEDIATELY BEFORE USE ON/NEAR TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740066 MLX 300W XENON LIGHTSOURCE N/A FCW INTEGRA YORK, PA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1