BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISISTAT 35W 6/BOX

    MDR report key: 14697210 · Received June 15, 2022

    Report

    Report Number
    3003898360-2022-00252
    Event Type
    Malfunction
    Date Received
    June 15, 2022
    Date of Event
    June 10, 2022
    Report Date
    June 13, 2022
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    QQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    (B)(4), PER DHR THE PRODUCT VISISTAT 35W 6/BOX LOT # 73A2200157 WAS MANUFACTURED ON 01/04/2022 A TOTAL OF (B)(4) PIECES. LOT WAS RELEASED ON 01/25/2022. DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. THE CUSTOMER RETURNED ONE UNIT OF 528235 VISISTAT 35W 6/BOX FOR INVESTIGATION. THE RETURNED STAPLER WAS VISUALLY EXAMINED WITH AND W ITHOUT MAGNIFICATION. VISUAL EXAMINATION OF THE RETURNED SAMPLE REVEALED THAT THE TRIGGER WAS LOOSE, AND THE PAWL WAS OUT OF PLACE. THE RAIL AND BOTTOM WERE DETACHED FROM THE COVER BLOCK. THE STAPLES AND PUSHER WERE NOT RETURNED. IT APPEARS THAT THE BOTTOM WAS NOT PROPERLY WELDED ONTO THE COVER BLOCK, WHICH WOULD CAUSE THE STAPLES AND PUSHER TO FALL OUT OF THE STAPLER. A NONCONFORMANCE WAS OPENED BY THE MANUFACTURING SITE TO ADDRESS THIS ISSUE. EVIDENCE OF USE IN THE FORM OF BIOLOGICAL MATERIAL WAS OBSERVED ON THE RETURNED SAMPLE. IT APPEARS THAT THE BOTTOM WAS NOT PROPERLY WELDED TO THE COVER BLOCK, WHICH ALLOWED THE STAPLES TO FALL OUT FROM THE STAPLER. A NONCONFORMANCE WAS BEEN OPENED BY THE MANUFACTURING SITE TO ADDRESS THIS ISSUE. THE REPORTED COMPLAINT OF "DETACHED - STAPLE FEED ASSEMBLY" WAS CONFIRMED BASED ON THE RETURNED SAMPLE. THE STAPLER WAS RETURNED WITH THE BOTTOM DETACHED FROM THE COVER BLOCK. IT APPEARS THAT THE BOTTOM WAS NOT PROPERLY WELDED TO THE COVER BLOCK, WHICH ALLOWED THE STAPLES TO FALL OUT FROM THE STAPLER. A NONCONFORMANCE WAS OPENED BY THE MANUFACTURING SITE TO ADDRESS THIS ISSUE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 0

    WHILE IN USE ON A PATIENT, THE STAPLER FELL APPART COMPLETELY AND ALL THE STAPLES FELL ON THE WOUND. THE STAPLES WERE REMOVED BY THE SURGEON.

    Description of Event or Problem · 0

    WHILE IN USE ON A PATIENT, THE STAPLER FELL APART COMPLETELY AND ALL THE STAPLES FELL ON THE WOUND. THE STAPLES WERE REMOVED BY THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1657419 VISISTAT 35W 6/BOX STAPLE, REMOVABLE (SKIN) QQS TELEFLEX MEDICAL IPN028493 73A2200157

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention