BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 36KHZ TUBING SET

    MDR report key: 5976533 · Received September 26, 2016

    Report

    Report Number
    3006697299-2016-00184
    Event Type
    Malfunction
    Date Received
    September 26, 2016
    Date of Event
    August 18, 2016
    Report Date
    August 29, 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 COMPLETED ITS INTERNAL INVESTIGATION 11/16/2016. THE INVESTIGATION INCLUDED: METHOD: -DHR REVIEW. -TREND ANALYSIS. -DEVICE EVALUATION. RESULTS: ACCORDING TO THE DHR REVIEW, NO ANOMALIES WERE REPORTED DURING THE PACKAGING PROCESSES OF THIS LOT THAT COULD BE RELATED TO THE REPORTED CONDITION. NO SIMILAR COMPLAINTS RELATED TO ¿HAIR FOUND IN STERILE PACKAGING¿ HAVE BEEN REPORTED FOR THE FG LOT 1152894. AFTER REVIEWING THE COMPLAINT SYSTEM FROM AUGUST 2014 TO AUGUST 2016, THREE (3) COMPLAINTS RELATED TO ¿HAIR FOUND IN STERILE PACKAGING¿ HAVE BEEN REPORTED IN THE CUSA MANIFOLD TUBING FAMILY. THE COMPLAINT OCCURRENCE RATE FOR THE REPORTED FAILURE IS APPROXIMATELY 0.00001. THE VISUAL EVALUATION OF THE DEVICE IDENTIFIED THAT A HAIR WAS INSIDE THE PACKAGING. CONCLUSION: THE EVALUATION OF THE COMPLAINT UNIT COULD NOT CONFIRM THE REPORTED CONDITION SINCE IT WAS OBSERVED THE PACKAGE OF THE RETURNED UNIT WAS RECEIVED OPENED. SINCE THE COMPLAINT UNIT WAS RECEIVED OPENED, AND THERE WAS NO ANOMALIES FOUND IN THE MANUFACTURING PROCESS THE POSSIBLE ROOT CAUSE MAY BE RELATED THAT A HAIR FELL INTO THE OPENED PACKAGING IN THE FIELD.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A HAIR WAS FOUND IN THE STERILE PACKAGE OF THE C3601 CUSA EXCEL 36KHZ TUBING SET. A PATIENT WAS PREPPED FOR A CRANIOTOMY SURGERY. THERE WAS NO DELAY IN SURGERY SINCE THE INCIDENT WAS DISCOVERED DURING THE SET UP OF THE CASE. THE PATIENT HAD A SUCCESSFUL SURGERY AND OUTCOME. NO FURTHER PATIENT DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629877 CUSA EXCEL 36KHZ TUBING SET ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES(IRELAND) 1152894

    Patients

    Seq Age Sex Outcome Treatment
    1