BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCISSORS INSERT CEV605-1 350MM DIA 5MM

    MDR report key: 10276590 · Received July 15, 2020

    Report

    Report Number
    2523190-2019-00152
    Event Type
    Injury
    Date Received
    July 15, 2020
    Date of Event
    December 4, 2019
    Report Date
    December 7, 2019
    Manufacturer
    INTEGRA MICROFRANCE S.A.S.
    Product Code
    GEI
    PMA / PMN Number
    K993655
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED ON 03JAN2020 STATED THAT A 78-YEAR-OLD FEMALE HAD A CHOLECYSTECTOMY BY LAPAROSCOPY PROCEDURE AND AT THE END OF THE SURGERY, HAD A THIRD-DEGREE BURN, 1 CM WITH 5 MM DIAMETER UNDER HER MAMMARY REGION. THE TREATMENT THAT WAS PROVIDED WAS A PARAFFIN GAUZE DRESSING. PRODUCT WAS RETURNED FOR EVALUATION. DHR FOR LOT NO. 1943754 REVIEWED AND NO ANOMALIES THAT COULD BE ASSOCIATED WITH THE COMPLAINT WERE OBSERVED. THE EVALUATION WAS UNABLE TO CONCLUSIVELY VERIFY THE COMPLAINT AS VALID. THEREFORE AN INVESTIGATION FOR CAUSE WAS UNABLE TO BE PERFORMED. THE DEVICE IS COMPLIANT WITH THE SPECIFICATIONS. THE INVESTIGATION DID NOT HIGHLIGHT ANY DEFECT. THE REPORTED EVENT IS NOT RELATED TO THIS DEVICE. 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 (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 DONNA ENGLEMAN, 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 NUMBERS:2523190-2019-00150 AND 2523190-2019-00151.

    Description of Event or Problem · 1

    1 OF 3 REPORTS. A NURSE REPORTED THAT A PATIENT WAS BURNED DURING THE USE OF THE CEV605-1 SCISSORS INSERT 350MM DIA 5MM. ADDITIONAL INFORMATION WAS RECEIVED ON 19DEC2019 WITH THE FOLLOWING; THE EVENT DATE WAS (B)(6) 2019. THE EVENT DID NOT LEAD TO AN INCREASE IN THE SURGERY TIME. THE PATIENT WAS INJURED. REQUEST FOR ADDITIONAL INFORMATION HAS BEEN MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741261 SCISSORS INSERT CEV605-1 350MM DIA 5MM PFM16 GEI INTEGRA MICROFRANCE S.A.S. 1943754

    Patients

    Seq Age Sex Outcome Treatment
    1