BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 23KHZ STANDARDTIP

    MDR report key: 5245727 · Received November 24, 2015

    Report

    Report Number
    3006697299-2015-00164
    Event Type
    Malfunction
    Date Received
    November 24, 2015
    Date of Event
    October 28, 2015
    Report Date
    October 30, 2015
    Manufacturer
    INTEGRA LIFESCIENCES (IRELAND) LTD.
    Product Code
    LFL
    PMA / PMN Number
    K141674
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON (B)(6) 2015. THE INVESTIGATION INCLUDED: METHODS: EVALUATION OF ACTUAL DEVICE. REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINTS HISTORY. RESULTS: COMPLAINT CONFIRMED: END OF THE TIP BROKE OFF NEAR ASPIRATION HOLES. NO APPARENT CEM USE. HOWEVER, THE SURFACE IS SCRATCHED BELOW THE BREAKAGE POINT. DEVICE HISTORY RECORD (DHR) OF THE FINISHED GOODS (FG) LOT # 1152043 WAS REVIEWED AS PART OF THIS INVESTIGATION TO IDENTIFY IF ANY DISCREPANCY WAS REPORTED DURING THE INSPECTION OR MANUFACTURING PROCESS OF THE PRODUCT WHICH COULD BE RELATED WITH THE REPORTED CONDITION BEING INVESTIGATED. THE MANUFACTURING DATE OF FG LOT # 1152043 IS 05-2015 AND THE EXPIRATION DATE IS 05-2018. BASED ON DHR REVIEW, NO ANOMALIES OCCURRED DURING PACKAGING PROCESSES OF THE REPORTED LOT 1152043 WHICH COULD CONTRIBUTE AND/OR BE RELATED TO REPORTED CONDITION. UPON REVIEW OF INTEGRA¿S COMPLAINT SYSTEM FROM 2013 ¿ 2015, A TOTAL OF THREE (3) COMPLAINTS (INCLUDING THE INVESTIGATION UNDER THIS REPORT) RELATED TO ¿TIP BROKE OFF BEFORE USE¿ FOR CUSA TIPS AND FLUES PRODUCTS HAVE BEEN REPORTED. APPROXIMATELY (B)(4) UNITS OF CUSA TIPS AND FLUES HAVE BEEN RELEASED FOR DISTRIBUTION SINCE JANUARY 2013 ¿NOVEMBER 03, 2015, RESULTING IN A COMPLAINT OCCURRENCE RATE OF APPROXIMATELY (B)(4)%. CONCLUSION: NO ASSIGNABLE CAUSES THAT COULD BE ASSOCIATED TO THE MANUFACTURING PROCESS WERE IDENTIFIED BASED ON THE REVIEW OF DEVICE HISTORY RECORD (DHR), CAPA'S, NCR'S AND SCAR'S HISTORY. PER THE CUSA EXCEL OPERATOR'S MANUAL, "DURING SURGERY, DO NOT ALLOW THE HANDPIECE TIP TO TOUCH METAL OBJECTS SUCH AS STAPLES, CLIPS, INSTRUMENTS, ETC. HANDPIECE TIP DAMAGE WILL RESULT".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP BROKE OFF BEFORE USE. NO ADVERSE EVENT REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 13 NOV 2015 WITH THE FOLLOWING: AFTER 30 MINUTES OF CLINICAL USE FOR A LIVER RESECTION PROCEDURE, THE END OF THE TIP WAS NOTICED TO HAVE BENT TO 90 DEGREES TO THE SHAFT. IT WAS IMMEDIATELY REMOVED FROM THE OPERATIVE FIELD AND THE TIP WAS REPLACED WITH A NEW ONE. THE PROCEDURE THEN CONTINUED. ON INSPECTION, THE BREAK HAD OCCURRED AT THE LEVEL OF THE ASPIRATION HOLES. NO FURTHER INFORMATION AVAILABLE ABOUT PATIENT AGE OR GENDER. DELAY IN SURGERY WAS "A FEW MINUTES ONLY." PATIENT OUTCOME WAS REPORTED AS "SURGERY COMPLETED SUCCESSFULLY, NO PATIENT INJURY." IT WAS NOTED THAT THIS HOSPITAL DOES NOT USE OR EVEN STOCK THE CEM NOSECONE. IT WAS REPORTED THAT THE BROKEN PART OF THE TIP WAS STILL ATTACHED TO THE CUSA TIP WHEN IT WAS NOTICED AND THAT THE BROKEN BIT DID NOT FALL INTO THE OPERATIVE FIELD. WHEN THE SALES REPRESENTATIVE RECEIVED THE COMPLAINT CUSA TIP FROM THE USER FACILITY, THE BROKEN PART OF THE TIP WAS ALREADY DETACHED FROM THE MAIN PART OF THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777465 CUSA EXCEL 23KHZ STANDARDTIP ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES (IRELAND) LTD. 1152043

    Patients

    Seq Age Sex Outcome Treatment
    1