BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 36KHZ TUBING SET

    MDR report key: 8438177 · Received March 20, 2019

    Report

    Report Number
    3006697299-2019-00037
    Event Type
    Malfunction
    Date Received
    March 20, 2019
    Date of Event
    January 28, 2019
    Report Date
    February 26, 2019
    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 · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE PHOTO PROVIDED WAS NOT ENOUGH TO ANALYZE THE FOREIGN MATTER ACCORDING TO INTEGRA QUALITY CONTROL INSPECTION CRITERIA. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ANOMALY WAS OBSERVED THAT COULD CAUSE THE REPORTED CONDITION. THE REPORTED COMPLAINT WAS NOT CONFIRMED. THE ROOT CAUSE EVENT WAS UNDETERMINED. DEVICE IDENTIFIER NUMBER: (B)(4). PRODUCT IDENTIFIER: (17)210831(10)3064388.

    Additional Manufacturer Narrative · 0

    TWO (2) UNITS WERE RECEIVED FOR EVALUATION. BOTH UNITS WERE OF LOT 3064388 AS REPORTED IN COMPLAINT. ONE LOOSE WHITE PARTICLE WAS OBSERVED ON THE HANDPIECE CLIP. THE PARTICLE WAS MEASURED USING A TAPPI DIRT ESTIMATION CHART AND THE PARTICLE WAS SLIGHTLY OVER 0.10 MM2. FOR THE SECOND UNIT, THE CUSTOMER MARKED THE AREA WHERE THE FOREIGN MATERIAL WAS NOTICED. A FINE LINE WAS EMBEDDED IN THE PAPER BAND. THE LINE WAS VERY THIN AND ALMOST UNNOTICEABLE (REQUIRED MAGNIFICATION TO BE SEEN); WHEN MAGNIFIED IT WAS CLEARLY SEEN AS A BROWNISH COLORED LINE. THE REPORTED COMPLAINT WAS CONFIRMED. THE REPORTED FOREIGN MATERIAL WAS NOT DETECTABLE UNDER THAT TYPE OF INSPECTION.

    Description of Event or Problem · 0

    N/A

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT YET RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT ON (B)(6) 2019, TWO PIECES OF THE C3601 CUSA EXCEL 36KHZ TUBING SET WERE REJECTED DURING INCOMING INSPECTION DUE TO A FOREIGN MATERIAL NOTED. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230525 CUSA EXCEL 36KHZ TUBING SET ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES(IRELAND) 3064388

    Patients

    Seq Age Sex Outcome Treatment
    1