BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 36KHZ STRAIGHT HANDPIECE

    MDR report key: 6272686 · Received January 24, 2017

    Report

    Report Number
    3006697299-2017-00003
    Event Type
    Malfunction
    Date Received
    January 24, 2017
    Date of Event
    December 12, 2016
    Report Date
    December 16, 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

    INVESTIGATION COMPLETED 3/02/2017. METHOD: -DHR REVIEW, -TREND ANALYSIS, - FAILURE ANALYSIS. THE DHR FOR CUSA EXCEL HANDPIECE C2602 SERIAL NUMBER (B)(4); WORK ORDER 241983 MANUFACTURED IN (B)(6), TRANSDUCER SERIAL NUMBER (B)(4), WAS REVIEWED AND NO ANOMALIES THAT COULD BE ASSOCIATED WITH THE COMPLAINT WERE OBSERVED. DATE OF MANUFACTURE: SEP-2015 NO SERVICE HISTORY FOR CUSA EXCEL HANDPIECE C2602 SERIAL NUMBER (B)(4) WAS PROVIDED BY (B)(4) SERVICE CENTRE IN TRACKWISE ¿ NO DATE OF LAST REPAIR RECORDED; THIS IS THE 1ST TIME THAT THE HANDPIECE WAS RETURNED FOR SERVICE. . THE DHR REVIEW HAS BEEN DEEMED SATISFACTORY RATE OF OCCURRENCE: DURING THE TIME PERIOD ¿DEC-15 TO FEB-17¿, THE GLOBAL PRODUCT USAGE FOR CUSA EXCEL HANDPIECES WAS CALCULATED AS (B)(4) USAGES, USING THE TOTAL QUANTITY OF CUSA EXCEL CONSOLE TUBING SALES SOLD TO CALCULATE THE QUANTITY OF USAGES. 1 TUBING SET IS USED PER OPERATION / PROCEDURE, AND IS USED AS A MEANS OF QUANTIFYING THE NUMBER OF PROCEDURES UNDERTAKEN. THE QUANTITY OF 16 X COMPLAINTS OVER THE 12-MONTH PERIOD WITH THE KEY WORDS IDENTIFIED IN THE COMPLAINT REVIEW CAN THEREFORE BE CALCULATED AS (B)(4) OF PROCEDURES. THIS PERCENTAGE IS BELOW THE PROBABILITY OF OCCURRENCE SCORED IN THE CUSA EXCEL MDHA CONCLUSION: PRODUCT WAS RETURNED AND THE EVALUATION VERIFIED THE COMPLAINT INCIDENT ¿HANDPIECE NOT RECOGNIZED¿ AS VALID. ROOT CAUSE DETERMINED; CAUSE OF THE POWER FAILURE WAS DUE TO FAULTY COIL FORM.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE C2602 CUSA EXCEL HP WAS REPORTED TO HAVE A PROBLEM WHEREIN THE HANDPIECE WAS NOT RECOGNIZED. THE HANDPIECE AND TIP WERE BEING ASSEMBLED AS INDICATED BUT CRACKED ON THE BLACK PART. THE TIP WAS THEN CHANGED BUT THE PROBLEM CONTINUED. THE (B)(6) MALE PATIENT WAS ANESTHETIZED IN PREPARATION FOR A CRANIAL TUMOR SURGERY. THE PATIENT WAS NOT INJURED, HOWEVER, THE INCIDENT LED TO AN INCREASE OF 30 MINUTES IN SURGERY TIME. THE DELAY HAD NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55350 CUSA EXCEL 36KHZ STRAIGHT HANDPIECE ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES(IRELAND)

    Patients

    Seq Age Sex Outcome Treatment
    1