BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISISTAT 35R 6/BOX

    MDR report key: 15526202 · Received October 2, 2022

    Report

    Report Number
    3003898360-2022-00552
    Event Type
    Malfunction
    Date Received
    October 2, 2022
    Date of Event
    September 20, 2022
    Report Date
    September 20, 2022
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    QQS
    UDI-DI
    14026704631770
    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 35R 6/BOX LOT# 73A2200582 INVESTIGATION DID NOT SHOW ISSUES RELATED TO THE COMPLAINT. THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE UNIT OF 528135 VISISTAT 35R 6/BOX FOR INVESTIGATION. THE RETURNED SAMPLE WAS VISUALLY EXAMINED WITH AND WI THOUT MAGNIFICATION. VISUAL EXAMINATION OF THE RETURNED SAMPLE REVEALED THAT THE FIRST STAPLES APPEARED PROPERLY ALIGNED. THE STAPLER WAS RETURNED WITH 39 STAPLES REMAINING IN THE COVER BLOCK. THE TRIGGER WAS NOT RETURNED ENGAGED. NO CLEAR EVIDENCE OF USE IN THE FORM OF BIOLOGICAL MATERIAL WAS PRESENT ON THE DEVICE. AN ATTEMPT TO FIRE STAPLES WAS MADE BY ENGAGING THE TRIGGER OF THE STAPLER USING HAND PRESSURE. UPON ENGAGEMENT OF THE TRIGGER, THE FIRST STAPLE WAS FORMED PROPERLY. THE NEXT STAPLE FIRED ON ITS SECOND ATTEMPT. THE THIRD STAPLE FORMED PROPERLY. THE FOURTH STAPLE DID NOT FORM PROPERLY. THE NEXT SIX STAPLES FIRED PROPERLY. 10 STAPLES WERE FIRED INTO A SIMULATED SKIN PAD. AFTER THIS, THE NEXT TWO STAPLES MISFIRED. UPON ADDITIONAL VISUAL INSPECTION, IT APPEARED THAT STAPLES HAD BECOME CROOKED IN THE COVER BLOCK. IT APPEARED THAT THE STAPLE MISALIGNMENT PREVENTED THE REMAINING STAPLES FROM MOVING DOWN THE TRACK AND FIRING CORRECTLY. THE DEVICE WAS DISASSEMBLED, AND NO DEFECTS OR ANOMALIES WERE OBSERVED. THE SAMPLE WAS SENT TO THE TECATE MANUFACTURING SITE FOR ADDITIONAL EVALUATION. AT THE TECATE MANUFACTURING SITE, A VISUAL INSPECTION OF COMPONENTS (PUSHER, STAPLES, COVER BLOCK, AND RAIL) WAS PERFORMED, AND NO BURRS WERE OBSERVED. THE COMPONENTS WERE OBSERVED TO BE CORRECTLY ASSEMBLED. THE FI RST MISALIGNED STAPLE WAS MANUALLY REMOVED. AFTER THIS, 15 STAPLES FIRED AND FORMED CORRECTLY. ACCORDING TO THE EVALUATION CARRIED OUT BY TECATE AND MORRISVILLE, THE REPORTED COMPLAINT WAS CONFIRMED. IT COULD NOT BE DETERMINED WHAT EXACTLY CAUSED THE STAPLES TO MISALIGN. SEVERAL ACTIONS TO MITIGATE DEFECTS FOR THIS ISSUE WERE ESTABLISHED AS PART OF AN NC, WHICH WAS CLOSED ON SEPTEMBER 14, 2022. THE RETURNED SAMPLE WAS MANUFACTURED PRIOR TO THESE CONTAINMENT ACTIONS AND CORRECTIONS. PER DHR THE PRODUCT VISISTAT 35R 6/BOX LOT # 73A2200582 WAS MANUFACTURED ON 01/18/2022 A TOTAL OF(B)(4) PIECES. LOT WAS RELEASED ON 01/31/2022. DHR INVESTIGATION DID NOT SHOW ISSUES RELAT ED TO COMPLAINT. THE IFU FOR THIS PRODUCT, L02644, WAS REVIEWED AS A PART OF THIS COMPLAINT INVESTIGATION. THE IFU STATES, "TO OBTAIN OPTIMUM STAPLE CLOSURE, THE TRIGGER MUST BE SQUEEZED ALL THE WAY IN." EACH STAPLER IS FIRED THREE TIMES AND THEN 100% INSPECTED FOR PROPER STAPLE ALIGNMENT AT THE MANUFACTURING SITE. FOR THIS REASON, IT IS UNLIKELY THAT THE ISSUE WAS PRESENT AT THE TIME OF ASSEMBLY. IT COULD NOT BE DETERMINED WHAT CAUSED THE STAPLES TO MISALIGN. SEVERAL ACTIONS TO MITIGATE DEFECTS FOR THIS ISSUE WERE ESTABLISHED AS PART OF THE NC, WHICH WAS CLOSED ON SEPTEMBER 14, 2022. THE RETURNED SAMPLE WAS MANUFACTURED PRIOR TO THESE ACTIONS. THE REPORTED COMPLAINT OF "MISFIRE/JAMMING - STAPLES NOT FIRING" WAS CONFIRMED BASED UPON THE SAMPLE RECEIVED. VISUAL EXAMINATION REVEALED THAT THE STAPLES BECAME MISALIGNED. UPON FUNCTIONAL INSPECTION, THE MISALIGNMENT OF THE STAPLES PREVENTED STAPLES FROM FIRING PROPERLY. THE SAMPLE WAS DISASSEMBLED, AND NO DEFECTS OR ANOMALIES WERE OBSERVED. EACH STAPLER IS FIRED THREE TIMES AND THEN 100% INSPECTED FOR PROPER STAPLE ALIGNMENT AT THE MANUFACTURING SITE. FOR THIS REASON, IT IS UNLIKELY THAT THE ISSUE WAS PRESENT AT THE TIME OF ASSEMBLY. THE SAMPLE WAS SENT TO THE TECATE MANUFACTURING SITE FOR ADDITIONAL EVALUATION. IT COULD NOT BE DETERMINED WHAT CAUSED THE STAPLES TO MISALIGN. AN NC WAS OPENED BY THE MANUFACTURING SITE TO ADDRESS THIS ISSUE. THE RETURNED SAMPLE WAS MANUFACTURED PRIOR TO THE CONTAINMENT ACTIONS AND CORRECTIONS ESTABLISHED TO ADDRESS THIS ISSUE IN THE NC. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STAPLE WAS JAMMING. THERE WAS NO REPORTED INJURY. THE DEVICE WAS REPLACED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STAPLE WAS JAMMING. THERE WAS NO REPORTED INJURY. THE DEVICE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2315989 VISISTAT 35R 6/BOX STAPLE, REMOVABLE (SKIN) QQS TELEFLEX MEDICAL IPN028492 73A2200582 14026704631770

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown