BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 23KHZ STANDARDTIP

    MDR report key: 5317947 · Received December 22, 2015

    Report

    Report Number
    3006697299-2015-00179
    Event Type
    Malfunction
    Date Received
    December 22, 2015
    Report Date
    December 4, 2015
    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 01/25/2016. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. DEVICE HISTORY RECORD REVIEWED FOR THIS PRODUCT ID LOT # 1130786 MANUFACTURED ON OCTOBER 17, 2012 SHOWED NO ABNORMALITIES RELATED TO THE REPORTED FAILURE. THIS DEVICE PASSED ALL REQUIRED INSPECTION POINTS WITH NO ASSOCIATED MRR¿S, VARIANCES OR REWORK. A TWO YEAR REVIEW OF COMPLAINTS HISTORY FOR THIS REPORTED FAILURE AND OR RELATED TO "TIP BROKE " FOR THIS PRODUCT FAMILY SHOWS THAT 14 COMPLAINTS WERE RECEIVED INCLUDING THIS CASE. NO NEW DESIGN OR MANUFACTURING TRENDS HAVE BEEN IDENTIFIED HOWEVER THIS ISSUE WILL BE MONITORED. IN SUMMARY, THE ITEM IN QUESTION WAS NOT RELEASED FOR EVALUATION THEREFORE THE ROOT CAUSE TO THE END USER'S EXPERIENCE COULD NOT BE DETERMINED. THIS COMPLAINT WILL BE REOPENED SHOULD THE PRODUCT BE RECEIVED. LINKED TO MFG. REPORT NUMBER: 1222895-2015-00052.

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 09/19/2016. THE INVESTIGATION INCLUDED: METHODS: EVALUATION OF ACTUAL DEVICE. REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINTS HISTORY. RESULTS: DEVICE HISTORY RECORD REVIEWED FOR THIS PRODUCT ID LOT # 1130786 MANUFACTURED ON OCTOBER 17, 2012 SHOW NO ABNORMALITIES RELATED TO THE REPORTED FAILURE. THIS DEVICE PASSED ALL REQUIRED INSPECTION POINTS WITH NO ASSOCIATED MRR¿S, VARIANCES OR REWORK. A TWO YEAR LOOKBACK IN (B)(6) FOR THIS REPORTED FAILURE AND OR RELATED TO "TIP BROKE " FOR THIS PRODUCT FAMILY SHOWS THAT 14 COMPLAINTS WERE RECEIVED INCLUDING THIS CASE. NO NEW DESIGN OR MANUFACTURING TRENDS HAVE BEEN IDENTIFIED HOWEVER THIS ISSUE WILL BE MONITORED. CONCLUSION: THE CUSTOMER REPORTED THAT THE C4601S CUSA EXCEL TIP BROKE DURING SURGERY. THE EVALUATION OF THE RETURNED CUSA TIP CONFIRMED THAT THE TIP HAD FRACTURED AT THE AERATION PORTS. THE BROKEN EDGES WERE JAGGED OR FRAGMENTED. IN ADDITION, A PORTION OF THE METAL SURFACE AT THE BREAKAGE POINT WAS DISCOLORED (BURNT). SCRATCHES WERE OBSERVED ALONG THE LENGTH OF THE TIP. THE REPORTED COMPLAINT OF ¿THE C4601S TIP BROKE¿ WAS CONFIRMED. THE ROOT CAUSE OF THE DAMAGE WAS NOT CONCLUSIVELY DETERMINED BUT, IS CONSISTENT TO CONTACT WITH A METAL INSTRUMENT DURING USE. CUSA EXCEL - EXCEL+ USER'S GUIDE 60903711 ISSUE, PAGE 1-5. STATES ¿WHEN THE HANDPIECE IS POWERED ON, CONTACT OF THE TIP WITH A HARD SURFACE (E.G. A METAL INSTRUMENT, TRAY, STAPLES, CLIPS, INSTRUMENTS, ETC.) MAY DAMAGE THE TIP OF THE HANDPIECE AND REQUIRE REPLACEMENT BEFORE USE."

    Description of Event or Problem · 1

    THIS IS THE FIRST OF TWO REPORTS (SAME PRODUCT ID, SAME LOT NUMBER, SAME PRODUCT PROBLEM, DIFFERENT PATIENTS). THIS REPORT IS IN REGARDS TO THE FIRST PATIENT. IT WAS REPORTED THAT THE TIP BROKE DURING HEPATIC (LIVER) SURGERY. THE DEVICE WAS IN CONTACT WITH THE PATIENT WHEN IT BROKE HOWEVER, THERE WAS NO PATIENT INJURY. THE EVENT DID LEAD TO AN INCREASE IN SURGERY OF 1 OR 2 HOURS. THE STAFF WAS ABLE TO FINISH THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845402 CUSA EXCEL 23KHZ STANDARDTIP ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES(IRELAND) 1130786

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR