BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSA EXCEL 23KHZ STANDARD TIP

    MDR report key: 4687125 · Received April 10, 2015

    Report

    Report Number
    2648988-2015-00033
    Event Type
    Injury
    Date Received
    April 10, 2015
    Date of Event
    February 10, 2015
    Report Date
    March 16, 2015
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    LFL
    PMA / PMN Number
    K141674
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION 06/08/2015. METHOD: EVAL OF ACTUAL DEVICE; REVIEW OF DEVICE HISTORY RECORDS; REVIEW OF COMPLAINT HISTORY. RESULTS: THE TIP BREAKAGE IS CONFIRMED; FG LOT # 1141530, FG RELEASE DATE 05/29/2014 AND FG PACKAGING DATE: 05/09/2014. DEVICE HISTORY RECORD (DHR) OF FINISHED GOODS (FG) LOT #141530 WAS REVIEWED BUT NO ANOMALIES WERE FOUND DURING THE PACKAGING AND STERILIZATION PROCESSES. A CERTIFICATE OF CONFORMANCE AND TEST, ISSUED BY (B)(4), CONFIRMED THAT THE LOT OF TIPS SATISFACTORILY PASSED ALL THEIR INTERNAL QUALITY CONTROL REQUIREMENTS AND TESTS. THE LOT WERE RECEIVED AND RELEASED FOR THE MANUFACTURING AND PACKAGING PROCESS BASED ON THIS CERTIFICATION. NO DEVIATIONS OR DISCREPANCIES WERE REPORTED DURING THE PACKAGING AND SEALING PROCESSES THAT COULD BE RELATED TO THE REPORTED CONDITION. AFTER THE REVIEW OF THE COMPLAINT HISTORY FROM 2013 TO THE PRESENT (04/16/2015)M TWO (2) COMPLAINTS INCLUDING THIS ONE HAVE BEEN ISSUED REGARDING FG LOT #1141530. BOTH WERE ALSO RELATED TO "BROKEN TIPS." TWENTY (20) COMPLAINTS, INCLUDING THIS ONE, HAVE BEEN REPORTED AT INTEGRA ASSOCIATED TO "BROKEN TIP." APPROXIMATELY (B)(4) UNITS OF CUSA TIPS AND FLUES PRODUCTS HAVE BEEN RELEASED FOR DISTRIBUTION FROM 01/01/2013 UNTIL 04/16/2015 RESULTING IN A COMPLAINT OCCURRENCE RATE OF APPROXIMATELY (B)(4). CONCLUSION: REASON FOR TIP BREAKAGE CANNOT BE DETERMINED. THIS TIP WAS USED WITH CEM, WHICH MAY HAVE CONTRIBUTED TO ITS FAILURE.

    Additional Manufacturer Narrative · 1

    THIS IS THE SECOND REPORT OF TWO INVOLVING A C 4601C 23KHZ TIP THAT BROKE DURING SURGERY. CROSS REF WITH MFR REPORT # 2648988-2015-00034 ((B)(4)). FURTHER CLARIFICATION RECEIVED ON 04/13/2015 WAS AS FOLLOWS: THERE WAS NO REVISION REQUIRED AND THE PT WAS NOT INJURED FROM THE TIP BREAKAGE ACCIDENT.

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A C4601S STANDARD TIP BROKE DURING A PROCEDURE. THE FOLLOWING INFORMATION WAS PROVIDED; THEY CHANGED THE NEW C4601S TIP (LOT NO. 1141530, EXP.: 2017-05) TO C2600 ON (B)(6) 2015. THEY SWITCHED OFF THE CUSA EXCEL MAIN SWITCH. THEY OPEN THE CUSA EXCEL MAIN SWITCH. THEY PUSHED THE "TEST" BUTTON. TIP WAS BROKEN IN TWO PARTS AFTER 15 MINUTES. THE PANEL SHOWED THE TIP ALARM. WAS THE TIP IN CONTACT WITH THE PATIENT WHEN IT BROKE: NO. DID ANY OF THE PIECES FALL INTO THE PATIENT: NO. WAS THE SURGEON ABLE TO RETRIEVE ALL OF THE PIECES THAT BROKE: YES. DID IT BREAK DURING TESTING PRIOR TO THE PROCEDURE OR DID IT BREAK DURING THE LIVER SURGERY: IT WAS BROKEN DURING THE LIVER SURGERY. WHAT WERE THE EQUIPMENT SETTINGS: SUCTION-70 IRRIGATION-70 AMPLITUDE-80. WERE THERE ANY OTHER INSTRUMENTS OR TOOLS BEING USED AT THE SAME TIME AND PROXIMITY AS THE CUSA TIP THAT FAILED: UNCERTAIN. PLEASE CONFIRM THAT THIS WAS THE FIRST TIME THIS TIP WAS USED. YES. WAS THE SURGERY DELAYED BECAUSE OF THIS ISSUE: NO. WAS THE PATIENT INJURED AS A RESULT OF THIS ISSUE OR BECAUSE OF A DELAY: NO. IF THERE WAS AN INJURY PLEASE DESCRIBE THE INJURY AND HOW IT WAS TREATED; THE DISTRIBUTOR DID NOT ANSWER THIS QUESTION. WAS A REVISION WAS REQUIRED: YES. DID THE PATIENT RECOVER FROM THE INJURY: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238683 CUSA EXCEL 23KHZ STANDARD TIP ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA NEUROSCIENCES PR 1141530

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention