BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 23KHZ TUBING SET

    MDR report key: 7937846 · Received October 5, 2018

    Report

    Report Number
    3006697299-2018-00057
    Event Type
    Malfunction
    Date Received
    October 5, 2018
    Date of Event
    September 11, 2018
    Report Date
    September 13, 2018
    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 PRODUCT WAS RETURNED FOR EVALUATION. ACCORDING TO THE DHR REVIEW, NO ANOMALIES WERE REPORTED DURING THE PACKAGING PROCESS OF THIS LOT THAT COULD BE RELATED TO THE REPORTED CONDITION. NO QUALITY EVENTS WERE ISSUED FOR LOT # 1170724, THEREFORE, THE LOT COMPLIED WITH ALL IN-PROCESS INSPECTIONS AND TESTING REQUIREMENTS AS SPECIFIED IN THE MANUFACTURING SHOP ORDER AND RELATED PROCEDURES. THE COMPLAINT CANNOT BE CONFIRMED SINCE THE UNIT WAS NOT IN ITS ORIGINAL PACKAGE. ALTHOUGH A PHOTO OF A UNIT INSIDE THE PACKAGE WAS PROVIDED BY THE CUSTOMER, IT IS CLEARLY OBSERVABLE THAT THE PACKAGE WAS ALREADY OPENED. HAIR IS ELECTROSTATICALLY ATTRACTED TO THE TUBING; THEREFORE, THE HAIR COULD BE PICKED UP AFTER OPENING THE PACKAGE. THE COMPLAINT IS UNCONFIRMED. (B)(4).

    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

    THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT DURING INCOMING INSPECTION OF GOODS ON (B)(6) 2018, A C3600 CUSA EXCEL 23KHZ TUBING SET WAS REJECTED BECAUSE A NURSE FOUND HAIR INSIDE THE PACKAGE. THE DEVICE WAS NOT IN CONTACT WITH THE PATIENT. NO SURGERY DELAY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779346 CUSA EXCEL 23KHZ TUBING SET ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES(IRELAND) 1170724

    Patients

    Seq Age Sex Outcome Treatment
    1