BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE CEV669B DIA 5MM ANG BIPOLAR

    MDR report key: 9310231 · Received November 12, 2019

    Report

    Report Number
    2523190-2019-00138
    Event Type
    Malfunction
    Date Received
    November 12, 2019
    Date of Event
    October 22, 2019
    Report Date
    October 25, 2019
    Manufacturer
    INTEGRA MICROFRANCE S.A.S.
    Product Code
    GEI
    PMA / PMN Number
    K993655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION:D10, G4, G7, H2, H3, H4, H6, H10. THE PRODUCT WAS RETURNED, AND THE EVALUATION VERIFIED THE COMPLAINT AS VALID. DHR FOR LOT NO. 2890369 REVIEWED AND NO ANOMALIES THAT COULD BE ASSOCIATED WITH THE COMPLAINT WERE OBSERVED. THE DEVICE DOESN'T PASS THE ELECTRICAL TEST. THE PLASTIC PART IS BURNT BETWEEN THE CONNECTORS. THE BURN OF THE PLASTIC PART IS THE CONSEQUENCE OF THE FORMATION OF AN ELECTRIC ARC, PROBABLY DUE TO THE PRESENCE OF HUMIDITY IN THE CONNECTION ZONE (CABLE NOT DRIED / BLOOD / TISSUES). IT CAN COME FROM A DEFECT OF CLEANING OR OF DRYING OF THE INSTRUMENT DESPITE THE RECOMMENDATIONS ON THE INSTRUCTIONS FOR USE. 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 (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 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 NUMBER:2523190-2019-00139.

    Description of Event or Problem · 1

    1 OF 2 REPORTS. IT WAS REPORTED THAT ON (B)(6) 2019, THERE WAS A SHORT CIRCUIT AND TRACE OF CALCINATION ON THE PLUG DURING THE USE OF THE CEV669B HANDLE DIA 5MM ANG BIPOLAR INSTRUMENT. THERE WAS PATIENT CONTACT, HOWEVER THERE WAS NO PATIENT INJURY AND THE EVENT DID NOT LEAD TO AN INCREASE IN THE SURGICAL TIME. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2019 STATED THAT THE TRACES OF CALCINATION WERE OBSERVED WHILE THE PATIENT WAS UNDER ANESTHESIA. THE SHORT-CIRCUITRY WAS DETECTED DUE TO A LIGHT SMOKE. PATIENT AGE, GENDER AND TYPE OF SURGERY WAS UNKNOWN. NO OTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1105950 HANDLE CEV669B DIA 5MM ANG BIPOLAR PFM16 GEI INTEGRA MICROFRANCE S.A.S. 2890369

    Patients

    Seq Age Sex Outcome Treatment
    1