BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 36KHZ CURVED EXTENDED STANDARDTIP

    MDR report key: 10276198 · Received July 15, 2020

    Report

    Report Number
    3006697299-2019-00145
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Report Date
    November 14, 2019
    Manufacturer
    INTEGRA LIFESCIENCES(IRELAND)
    Product Code
    LFL
    PMA / PMN Number
    K141674
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR) OF FINISHED GOOD (FG) LOT 1170042 WAS REVIEWED. NO ANOMALIES WERE REPORTED DURING THE PACKAGING PROCESS THAT COULD BE RELATED WITH THE REPORTED CONDITION BEING INVESTIGATED. THE LOT MET ALL IN PROCESS REQUIREMENTS AS SPECIFIED IN THE PACKAGING SHOP ORDER AND RELATED PROCEDURES. EVENT OF ¿THE TIP IS IN THE WRONG WAY¿ IS DIRECTLY RELATED TO THE TIP COMPONENT ¿36KHZ ANGLED PRECISION TIP CUSA EXCEL¿ (P/N 223400755). THE FG LOT 1170042 USED THE TIP LOT # 3163139. NO EVENTS HAVE BEEN REPORTED FOR THE TIP LOT (3163139). COMPLAINT ISSUE WAS CONFIRMED. C4614S CUSA EXCEL 36KHZ CURVED EXTENDED STANDARDTIP ORIENTATION WAS NOT CORRECT. THIS PRODUCT WAS MADE ON A BENDING / TIMING FIXTURE WITH A FUNCTIONAL TESTING PROCEDURE THAT DID NOT CONTAIN CRITERIA FOR INSPECTING THE ORIENTATION OF THE BEND. ROOT CAUSE DETERMINED TO BE LACK OF BEND ALIGNMENT VERIFICATION IN FUNCTIONAL TESTING PROCEDURE. UDI NUMBER: (B)(4). 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 NUMBERS: 3006697299-2019-00144.

    Description of Event or Problem · 1

    THIS IS 3 OF 3 REPORTS. A SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE C4614S CUSA EXCEL 36KHZ CURVED EXTENDED STANDARDTIP WAS IN THE WRONG DIRECTION AFTER ASSEMBLY WITH THE HANDPIECE. THE PRODUCT WAS IN CONTACT WITH THE PATIENT WITH NO INJURY/DEATH REPORTED. THE EVENT LEAD TO AN INCREASE OF SURGERY TIME. THE EXACT TIME OF THE DELAY WAS NOT KNOWN SINCE THREE TIPS HAD TO BE REPLACED; IT WAS REPORTED TO BE MAXIMUM OF A HALF AN HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739498 CUSA EXCEL 36KHZ CURVED EXTENDED STANDARDTIP ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES(IRELAND) 1170042

    Patients

    Seq Age Sex Outcome Treatment
    1