BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 36KHZ STRAIGHT HANDPIECE

    MDR report key: 10279963 · Received July 15, 2020

    Report

    Report Number
    3006697299-2020-00042
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Date of Event
    March 11, 2020
    Report Date
    March 23, 2020
    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

    UNIQUE DEVICE IDENTIFIER (UDI): (B)(4). DEVICE HISTORY RECORD (DHR) - THE DHR DOCUMENTATION WAS REVIEWED AND NO ANOMALIES THAT COULD BE ASSOCIATED WITH THE COMPLAINT INCIDENT WAS OBSERVED. CUSA 36KHZ HANDPIECE WAS RETURNED FOR EVALUATION. THE REPORTED COMPLAINT WAS CONFIRMED AND IS CONSISTENT WITH TRANSDUCER DELAMINATION BASED ON DATE OF MANUFACTURE (NEEDS TO BE BETWEEN 2019), FAILED STROKE, VIBRATION AND POWER TEST, AND CONFIRMED DEFECTIVE TRANSDUCER. ROOT CAUSE: TRANSDUCER DELAMINATION.

    Additional Manufacturer Narrative · 0

    DEVICE IDENTIFIER: (B)(4). PRODUCT IDENTIFIER: (B)(6). THE DEVICE WAS NOT RETURNED FOR EVALUATION THEREFORE THE FAILURE ANALYSIS AND DETERMINATION OF ROOT CAUSE WAS NOT POSSIBLE. BASED ON THE CUSTOMER REPORTED FAILURE ¿VIBRATION ALARM¿ ITS POSSIBLE THIS COMPLAINT WAS AS A RESULT OF A DEFECTIVE TRANSDUCER OR A TIP ISSUE. HOWEVER, WITHOUT TESTING IT IS NOT POSSIBLE TO VERIFY. THE DHR DOCUMENTATION WAS REVIEWED AND NO ANOMALIES THAT COULD BE ASSOCIATED WITH THE COMPLAINT INCIDENT WAS OBSERVED. THE REPORTED COMPLAINT WAS NOT CONFIRMED. 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)(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.

    Description of Event or Problem · 0

    N/A

    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

    A DISTRIBUTOR REPORTED THAT DURING INSPECTION ON (B)(6) 2020, A VIBRATION ALARM OCCURRED AT TEST WITH THE C2602 CUSA EXCEL 36KHZ STRAIGHT HANDPIECE. THERE WAS NO PATIENT CONTACT, INJURY OR DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741471 CUSA EXCEL 36KHZ STRAIGHT HANDPIECE ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES(IRELAND)

    Patients

    Seq Age Sex Outcome Treatment
    1 C4614S TIP