BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISISTAT 35R 6/BOX

    MDR report key: 15160308 · Received August 3, 2022

    Report

    Report Number
    3003898360-2022-00378
    Event Type
    Malfunction
    Date Received
    August 3, 2022
    Date of Event
    July 22, 2022
    Report Date
    July 27, 2022
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    QQS
    UDI-DI
    14026704631770
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4). THE DEVICE HISTORY REVIEW FOR THE PRODUCT VISISTAT 35R 6/BOX LOT# 73A2200161 INVESTIGATION DID NOT SHOW ISSUES RELATED TO THE COMPLAINT.

    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 WITHOUT MAGNIFICATION. VISUAL EXAMINATION REVEALED THAT EVIDENCE OF USE IN THE FORM OF BIOLOGICAL MATERIAL WAS PRESENT ON THE DEVICE. THE FIRST STAPLE WAS RETURNED PARTIALLY FORMED. THE STAPLER WAS RETURNED WITH 27 STAPLES REMAINING IN THE COVER BLOCK, INDICATING THAT AT LEAST 8 STAPLES WERE FIRED BY THE CUSTOMER. THE TRIGGER WAS RETURNED PARTIALLY ENGAGED. AN ATTEMPT TO FIRE STAPLES WAS MADE BY ENGAGING THE TRIGGER OF THE STAPLER USING HAND PRESSURE. UPON ENGAGEMENT OF THE TRIGGER, THE PARTIALLY FORMED STAPLE FORMED PROPERLY. HOWEVER, THE SECOND STAPLE WOULD NOT FIRE. THE STAPLER WAS DISASSEMBLED, AND A BUILDUP OF BIOLOGICAL MATERIAL WAS DISCOVERED. NO DEFECTS OR ANOMALIES WERE OBSERVED WITH THE DEVICE ITSELF. MANUAL REALIGNMENT OF THE STAPLES WAS ATTEMPTED. AFTER THIS, THE NEXT TWO STAPLES DID NOT FORM PROPERLY AND WERE MANUALLY REMOVED. THE FOLLOWING STAPLE WOULD NOT FIRE. ANOTHER MANUAL REALIGNMENT OF THE STAPLES WAS ATTEMPTED, BUT THE STAPLES STILL WOULD NOT FIRE SUCCESSFULLY. MULTIPLE ATTEMPTS WERE MADE, BUT NO STAPLES FIRED. IT APPEARED THAT MISALIGNMENT OF THE FIRST TWO STAPLES PREVENTED THE REMAINING STAPLES FROM MOVING DOWN THE TRACK AND FIRING. IT COULD NOT BE DETERMINED WHAT EXACTLY CAUSED THE FIRST TWO STAPLES TO MISALIGN. A NONCONFORMANCE WAS OPENED BY THE MANUFACTURING SITE TO ADDRESS THIS ISSUE. 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." IN SUMMARY, THE REPORTED COMPLAINT OF "MISFIRE/JAMMING-MULTIPLE STAPLES FIRING" WAS CONFIRMED BASED UPON THE SAMPLE RECEIVED. UPON FUNCTIONAL INSPECTION, A MISALIGNMENT OF THE FIRST TWO STAPLES PREVENTED THE REMAINING STAPLES FROM FIRING FOLLOWING SEVERAL MISFIRES. THE SAMPLE WAS DISASSEMBLED, AND BUILDUP OF BIOLOGICAL MATERIAL WAS DISCOVERED. NO DEFECTS OR ANOMALIES WERE OBSERVED WITH THE DEVICE. IT COULD NOT BE DETERMINED WHAT CAUSED THE STAPLES TO MISALIGN. 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

    ON FRIDAY WE HAD 2 STAPLERS THAT DID NOT DEPLOY CORRECTLY. WHEN WE USED THE STAPLER WOULD DEPLOY 3 AT A TIME AND THEN STICKS AND NOT LET GO. WE OPENED A THIRED STAPLER AND IT WORKED OK. THERE IS 2 LOT#'S INVOLVED.. 73A2200161 AND 73B2200012.

    Description of Event or Problem · 0

    ON FRIDAY, WE HAD 2 STAPLERS THAT DID NOT DEPLOY CORRECTLY. WHEN WE USED THE STAPLER, IT DEPLOYED 3 AT A TIME AND THEN STICKS AND NOT LET GO. WE OPENED A THIRD STAPLER AND IT WORKED OK. THERE IS 2 LOT #'S INVOLVED, 73A2200161 & 73B2200012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1703851 VISISTAT 35R 6/BOX STAPLE, REMOVABLE (SKIN) QQS TELEFLEX MEDICAL IPN028492 73A2200161 14026704631770

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown