BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MLX 300W XENON LIGHTSOURCE

    MDR report key: 10279221 · Received July 15, 2020

    Report

    Report Number
    2523190-2020-00024
    Event Type
    Injury
    Date Received
    July 15, 2020
    Date of Event
    January 29, 2020
    Report Date
    February 24, 2020
    Manufacturer
    INTEGRA LIFESCIENCES CORP
    Product Code
    FCW
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT WAS NOT RETURNED FOR EVALUATION. THE FIBER OPTIC CABLE ACCESSORIES MUST BE PREMIUM BIFURCATED CABLES. IT IS UNKNOWN IF THE NON-INTEGRA PRODUCT USED WITH THE 00MLX LIGHT SOURCE MEETS THE BIFURCATED STANDARD. NOTE THAT HOT CABLE END FITTINGS AND/OR HEAD LIGHTS CAN CAUSE BURNS WHEN IN CONTACT WITH UN-PROTECTED HANDS OR TISSUE. DEVICE IDENTIFIER (B)(4). BETWEEN (B)(6) 2019 AND (B)(6)2020, 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 (B)(6)2019 THROUGH(B)(6)2020. INTEGRA LIFESCIENCES CONTACTED DONNA ENGLEMAN, DIRECTOR OF REGULATORY PROGRAMS, OFFICE OF PRODUCT EVALUATION AND QUALITY AND MICHELLE RIOS, ASSISTANT DIRECTOR, MDR TEAM, OFFICE OF PRODUCT EVALUATION AND QUALITY ON (B)(6) 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.

    Description of Event or Problem · 1

    SUS VOLUNTARY EVENT REPORT FOI FOR MANUFACTURERS (MW5092762) WAS RECEIVED ON (B)(6) 2020 WITH THE FOLLOWING INFORMATION: ON (B)(6) 2020, THE 00MLX MLX 300W XENON LIGHTSOURCE CAUSED A BURN TO THE PATIENT. THE PATIENT SUSTAINED BURN ON THE LEFT THIGH AFTER THE LIGHTED URETERAL STENTS WERE TAPED. THE PORTABLE LIGHT BOX WAS USED TO CONNECT THE LIGHTED URETERAL STENTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743366 MLX 300W XENON LIGHTSOURCE N/A FCW INTEGRA LIFESCIENCES CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 KARL STORZ LIGHT CORD LOT #: ZT25| KARL STORZ LIGHTED URETERAL STENT LOT #: PQ01