BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 23KHZ STANDARDTIP

    MDR report key: 5500246 · Received March 15, 2016

    Report

    Report Number
    3006697299-2016-00106
    Event Type
    Malfunction
    Date Received
    March 15, 2016
    Date of Event
    January 11, 2016
    Report Date
    February 18, 2016
    Manufacturer
    INTEGRA LIFESCIENCES(IRELAND)
    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 11 MAY 2016. THE INVESTIGATION INCLUDED: METHODS: EVALUATION OF ACTUAL DEVICE. REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINT HISTORY. RESULTS: EVALUATION OF DEVICE: A VISUAL INSPECTION OF EACH PORTION UNDER MAGNIFICATION FOUND THE FRACTURED END OF ONE PORTION MATCHING THE END OF THE OTHER. IN ADDITION, SCRATCHES IN THE SURFACE WERE OBSERVED IN THE LOCATION OF THE FRACTURES. THE NATURE OF THE DAMAGE IS CONSISTENT WITH THE TIP COMING IN CONTACT WITH ANOTHER METAL OBJECT DURING OPERATION. THE BROKEN OFF PORTION OF THE TIP MEASURED 13.8MM. THE DHR REVIEW HAS BEEN DEEMED SATISFACTORY. ACCORDING TO THE DHR REVIEW CONDUCTED FOR FINISHED GOODS (FG) LOT 1150456 THERE IS NO INDICATION THAT THE PRODUCTION PROCESS OF THIS LOT CONTRIBUTED TO THE COMPLAINT EVENT. NO ANOMALIES WERE REPORTED DURING THE MANUFACTURING AND PACKAGING PROCESSES OF THIS LOT THAT COULD BE RELATED TO THE REPORTED CONDITION. NO TREND HAS BEEN IDENTIFIED. CONCLUSION: THE EVALUATION OF THE RETURNED CUSA TIP CONFIRMED A PORTION OF THE TIP MEASURING 13.8MM WAS VISIBLY DAMAGED. THE ROOT CAUSE OF THE DAMAGE WAS NOT CONCLUSIVELY DETERMINED BUT, IS CONSISTENT WITH CONTACT WITH A METAL OBJECT DURING USE. NO MANUFACTURING, WORKMANSHIP, OR MATERIAL DEFICIENCY HAS BEEN IDENTIFIED.

    Description of Event or Problem · 1

    THIS IS THE SECOND OF TWO REPORTS (SAME PRODUCT ID, SAME LOT NUMBER, SAME PRODUCT PROBLEM, DIFFERENT PATIENTS AND DIFFERENT INCIDENT DATES). THIS REPORT IS IN REGARDS TO THE SECOND PATIENT. LINKED TO MFG REPORT: 3006697299-2016-00105. IT WAS REPORTED THAT THE C4601S TIP WAS REPLACED ONTO C2600 ON (B)(6) 2016. THE USER SWITCHED OFF THE CUSA EXCEL MAIN SWITCH. THE USER OPENED THE CUSA EXCEL MAIN SWITCH THEN PUSHED THE "TEST" BUTTON. THE TIP WAS BROKEN IN TWO PARTS AFTER 10 MINUTES. THE PANEL SHOWED THE TIP ALARM. THIS INCIDENT OCCURRED DURING HEPATIC (LIVER) SURGERY. THE DEVICE WAS IN CONTACT WITH THE PATIENT WHEN IT BROKE, HOWEVER, THERE WAS NO PATIENT INJURY OR DEATH ALLEGED. THE EVENT DID LEAD TO AN INCREASE IN SURGERY TIME OF 20 MINUTES. THE MEDICAL STAFF WAS ABLE TO COMPLETE THE SURGERY BY REPLACING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156636 CUSA EXCEL 23KHZ STANDARDTIP ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES(IRELAND) 1150456

    Patients

    Seq Age Sex Outcome Treatment
    1