BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 36KHZ STRAIGHT HANDPIECE

    MDR report key: 9211166 · Received October 18, 2019

    Report

    Report Number
    3006697299-2019-00111
    Event Type
    Malfunction
    Date Received
    October 18, 2019
    Date of Event
    September 21, 2019
    Report Date
    September 23, 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

    DEVICE IDENTIFIER: (01)10381780039433 PRODUCT IDENTIFIER: (11)181017(21)HCK1805502IE THE DEVICE WAS RETURNED FOR EVALUATION. THE DHR WAS REVIEWED AND NO ANOMALIES THAT COULD BE ASSOCIATED WITH THE COMPLAINT INCIDENT WERE OBSERVED. THE COMPLAINT WAS VERIFIED AS VALID. THE TECHNICIAN FOUND THAT THE HANDPIECE HAD A FAULTY TRANSDUCER. 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 (B)(4) 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)(6) , DIRECTOR OF REGULATORY PROGRAMS, OFFICE OF PRODUCT EVALUATION AND QUALITY AND (B)(6) , ASSISTANT DIRECTOR, MDR TEAM, OFFICE OF PRODUCT EVALUATION AND QUALITY ON JULY 8-9, 2020 TO REPORT THESE ISSUES REGARDING MDR REPORTS.

    Additional Manufacturer Narrative · 1

    A COMPLAINT INVESTIGATION AND DETERMINATION OF ROOT CAUSE WAS NOT POSSIBLE SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ANOMALIES THAT COULD BE ASSOCIATED WITH THE COMPLAINT INCIDENT WERE OBSERVED. THE REPORTED COMPLAINT WAS NOT CONFIRMED. BASED ON THE CUSTOMER REPORTED FAILURE ¿VIBRATION ALERT¿ ITS POSSIBLE THIS COMPLAINT WAS A RESULT OF A DEFECTIVE TRANSDUCER. HOWEVER, WITHOUT TESTING, IT IS NOT POSSIBLE TO VERIFY. (B)(4). LINKED TO MFG REPORT NO.: 3006697299-2019-00112.

    Description of Event or Problem · 1

    THIS IS 1 OF 2 REPORTS. A DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT TWO C2602 CUSA EXCEL 36KHZ STRAIGHT HANDPIECES STOPPED WORKING ON 21SEP2019. BEFORE THE PLANNED SURGERY, THE USER CHECKED BOTH HANDPIECES WITH A CUSA CONSOLE AND FOUND THAT THEY DID NOT PASS THE SELF TEST AND BOTH HANDPIECES WERE GIVING PROBLEM OF FRAGMENTATION OUTPUT. AN ENGINEER FOR THE DISTRIBUTOR ATTENDED TO THE ISSUE AND FOUND THAT AFTER COMPLETING THE WAIT PERIOD WHEN THE AMPLITUDE TEST WAS PRESSED, THE HANDPIECE DID NOT PASS AND GAVE A VIBRATION ALERT. IN THE RUN MODE, WHEN THE ORANGE VIBRATION FOOT PEDAL WAS PRESSED, THERE WAS NO OUTPUT. THERE WAS NO KNOWN PATIENT CONTACT OR DELAY IN SURGERY REPORTED. FOR THE SURGERY, THE CUSTOMER USED A 23 KHZ HANDPIECE WHICH WAS FOUND TO BE WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1004917 CUSA EXCEL 36KHZ STRAIGHT HANDPIECE ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES(IRELAND)

    Patients

    Seq Age Sex Outcome Treatment
    1 CUSA CONSOLE