BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CUSA EXCEL

    MDR report key: 10280140 · Received July 15, 2020

    Report

    Report Number
    3006697299-2020-00053
    Event Type
    Injury
    Date Received
    July 15, 2020
    Report Date
    April 1, 2020
    Manufacturer
    INTEGRA LIFESCIENCES(IRELAND)
    Product Code
    LFL
    PMA / PMN Number
    K141668
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D10, G4, G7, H2, H3, H6, H10 THE DEVICE WAS NOT RETURNED FOR EVALUATION THEREFORE THE FAILURE ANALYSIS AND DETERMINATION OF ROOT CAUSE WAS NOT POSSIBLE. THE COMPLAINT IS CONSIDERED UNCONFIRMED. BASED ON THE CUSTOMER REPORTED FAILURE ¿SURGICAL SITE INFECTIONS LITERATURE¿ ITS NOT POSSIBLE TO DETERMINE A POSSIBLE CAUSE FOR THIS COMPLAINT. THIS COMPLAINT IS AS A RESULT OF A LITERATURE REVIEW. NO DHR REVIEW WAS POSSIBLE AS NO SERIAL OR LOT NUMBER WAS PROVIDED. 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)(4) OFFICE OF PRODUCT EVALUATION AND QUALITY ON JULY 8-9, 2020 TO REPORT THESE ISSUES REGARDING MDR REPORTS.

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE DEVICE INVOLVED WILL BE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. DOI: HTTP://DX.DOI.ORG/10.1016/J.AJIC.2016.11.020.

    Description of Event or Problem · 1

    AMERICAN JOURNAL OF INFECTION CONTROL (2016) PUBLISHED "AN OUTBREAK OF SURGICAL SITE INFECTIONS FOLLOWING CRANIOTOMY PROCEDURE ASSOCIATED WITH A CHANGE IN THE ULTRASONIC SURGICAL ASPIRATOR DECONTAMINATION PROCESS". EVENT DESCRIPTION ¿ THE AUTHORS INVESTIGATED AN OUTBREAK OF SURGICAL SITE INFECTIONS THAT OCCURRED IN A TERTIARY CARE HOSPITAL IN QUEBEC, CANADA. THIS INVESTIGATION REVEALED THAT A CHANGE IN THE STERILIZATION PROCESS OF THE ULTRASONIC SURGICAL ASPIRATOR MAY HAVE CAUSED THIS OUTBREAK. IT EMPHASIZES THE FACT THAT THE COMPLEX DESIGNS OF SURGICAL POWER TOOLS MAY RESTRICT ACCESS TO CLEANING AND STERILIZATION AGENTS. HEALTH CARE PROFESSIONALS SHOULD REVIEW MANUFACTURERS¿ ASSEMBLY/DISASSEMBLY INSTRUCTIONS AND STERILIZATION/DECONTAMINATION PROCEDURES BEFORE USE OF SUCH TOOLS. AFTER AUDITS AND INTERVIEWS, WE OBSERVED A TEMPORAL ASSOCIATION BETWEEN THE OUTBREAK AND A CHANGE IN STERILIZATION PROCESS OF THE CUSA. BEFORE JANUARY 2015, NURSES DISSEMBLED, RINSED, AND THOROUGHLY SCRUBBED THE CUSA IMMEDIATELY AFTER SURGERY IN THE OPERATING ROOM. FOR YEARS, THEY HAD FOLLOWED THE MANUFACTURER¿S INSTRUCTIONS AND REASSEMBLED THE CUSA WITH A STERILE SINGLE-USE CLEAR TIP AND TUBE BEFORE SENDING IT TO THE REPROCESSING UNIT FOR STERILIZATION. TO STANDARDIZE THE STERILIZATION METHOD OF SURGICAL INSTRUMENTS, ALL STEPS WERE RECOMMENDED TO BE PERFORMED IN THE REPROCESSING UNIT. THEREFORE, BEGINNING IN JANUARY 2015, THE CUSA WAS DISASSEMBLED IN THE OPERATING ROOM AFTER SURGERY, SENT TO THE REPROCESSING UNIT FOR CLEANING, RETURNED TO THE OPERATING ROOM FOR ASSEMBLING THE TIPS AND TUBES, AND SENT BACK TO THE REPROCESSING UNIT FOR STERILIZATION. ON JUNE 30, 2015, OUR CUSA WAS REPLACED BY THE SONASTAR (MISONIX, FARMINGDALE, NY) DEVICE AT OUR INSTITUTION. REPROCESSING THE SONASTAR IS SIMPLER THAN THE PROCESS REQUIRED FOR THE CUSA; SPECIFICALLY, IT DOES NOT NEED TO BE TRANSFERRED BETWEEN THE OPERATING ROOM AND THE REPROCESSING UNIT. TECHNICAL ISSUES AND CONCERNS REGARDING REPROCESSING MOTIVATED THIS CHANGE. SINCE CHANGING THE TOOL, ONLY 1 INTRACRANIAL DEEP AND ORGAN/SPACE SSI HAS OCCURRED BETWEEN JUNE 30, 2015, AND JUNE 30, 2016.¿ (TABLE 1 INCLUDES THE CHARACTERISTICS OF CASES) CONCLUSIONS - THE OUTBREAK¿S FEATURES SUGGEST THAT INFECTIONS WERE TRANSMITTED BY AN INADEQUATE CLEANING PROCESS PERFORMED IN THE STERILIZATION DEPARTMENT FOLLOWED BY SUBOPTIMAL STERILIZATION. IT EMPHASIZES THE FACT THAT SPTS HAVE COMPLEX DESIGNS THAT MAY RESTRICT ACCESS TO CLEANING AND STERILIZATION AGENTS. HEALTH CARE PROFESSIONALS SHOULD REVIEW AND ADHERE TO MANUFACTURERS¿ ASSEMBLY/DISASSEMBLY INSTRUCTIONS BEFORE USING SPTS. ADVERSE EVENTS: ENCOMPASSES MULTIPLE ADVERSE EVENTS WITH NO COMPLETE SPECIFIC PATIENT DEMOGRAPHICS ¿ CEREBRAL ABSCESS (3), EPIDURAL EMPYEMA (1), MENINGITIS (3) (CULTURES WERE DIFFERENT IN EACH CASE OF MENINGITIS; THERE WAS (1) STAPHYLOCOCCUS CAPITIS, (1) STREPTOCOCCUS AGALACTIAE, AND (1) ENTEROCOCCUS FAECALIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739797 UNKNOWN CUSA EXCEL ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES(IRELAND)

    Patients

    Seq Age Sex Outcome Treatment
    1