BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCEPS CEV134 BIPOLAR 350MM MOUIEL

    MDR report key: 10275793 · Received July 15, 2020

    Report

    Report Number
    2523190-2020-00030
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Date of Event
    February 28, 2020
    Report Date
    March 3, 2020
    Manufacturer
    INTEGRA MICROFRANCE S.A.S.
    Product Code
    GEI
    PMA / PMN Number
    K993655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT FRAGMENT WAS RETURNED FOR EVALUATION. ONE OF THE JAW WAS BROKEN. THE THICKNESS OF THE JAW NEAR THE BREAKAGE AREA WAS LOWER. NO NON-CONFORMITY OR SIMILAR COMPLAINT HAS BEEN REGISTERED CONCERNING LOT NUMBER: 4396814. DHR FOR LOT NO. 2935403 REVIEWED AND NO ANOMALIES THAT COULD BE ASSOCIATED WITH THE COMPLAINT WERE OBSERVED. THE EVALUATION VERIFIED THE COMPLAINT AS VALID. THE JAW WAS BROKEN BECAUSE THE MILLING WERE TOO DEEP. IT WEAKENS THE JAW AND GENERATE A BREAKAGE DURING THE REPROCESSING OR THE USE OF THE PRODUCT. THIS ISSUE WAS DUE TO HUMAN ERROR DURING THE FINISHING OPERATIONS DESPITE FINAL INSPECTION. 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.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC VESICLE PROCEDURE ON (B)(6) 2020, THE ¿PALETTE¿ OF THE CEV134 FORCEPS BIPOLAR 350MM MOUIEL BROKE. THE BROKEN PART WAS REMOVED FROM THE PATIENT¿S BELLY WITH ANOTHER BIPOLAR FORCEPS. THERE WAS A 5 TO 10 MINUTES MAXIMUM SURGICAL DELAY REPORTED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744543 FORCEPS CEV134 BIPOLAR 350MM MOUIEL PFM16 GEI INTEGRA MICROFRANCE S.A.S. 2935403

    Patients

    Seq Age Sex Outcome Treatment
    1