BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISISTAT 35W 6/BOX

    MDR report key: 14633464 · Received June 8, 2022

    Report

    Report Number
    3003898360-2022-00224
    Event Type
    Malfunction
    Date Received
    June 8, 2022
    Date of Event
    May 24, 2022
    Report Date
    May 24, 2022
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    QQS
    UDI-DI
    14026704631787
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE HISTORY REVIEW FOR THE PRODUCT VISISTAT 35W 6/BOX LOT# 73J1900729 INVESTIGATION DID NOT SHOW ISSUES RELATED TO THE COMPLAINT.

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. PART NUMBER 528235 IS NOT BEING MANUFACTURED CURRENTLY, HOWEVER, ANOTHER PART NUMBER FROM THE SAME FAMILY WAS USE FOR THE "VERIFICATION OF FAILURE MODE REPORTED IN THE CURRENT MANUFACTURING PROCESS" AND WAS CONDUCTED AS FOLLOWS: 13 STAPLERS WERE TAKEN FROM THE CURRENT PRODUCTION FROM PART NUMBER 528236 VISISTAT 35W NON-STERILE LOT# 73E2200856 THE STAPLERS WERE FUNCTIONALLY INSPECTED AND ISSUE REPORTED "FAILURE TO FUNCTION - OTHER" WAS NOT OBSERVED IN THE CURRENT MANUFACTURING PROCESS, THE STAPLES WERE LOADED AND RELEASED CORRECTLY. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE, THE COMPLAINT COULD NOT BE CONFIRMED, AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE. IF THE SAMPLE BECOMES AVAILABLE AT A LATER DATE A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.

    Description of Event or Problem · 0

    STAPLE MISALIGNED.

    Description of Event or Problem · 0

    STAPLE MISALIGNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12430 VISISTAT 35W 6/BOX STAPLE, REMOVABLE (SKIN) QQS TELEFLEX MEDICAL IPN028493 73J1900729 14026704631787

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown