BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISISTAT 35R 6/BOX

    MDR report key: 15160312 · Received August 3, 2022

    Report

    Report Number
    3003898360-2022-00377
    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# 73B2200012 INVESTIGATION DID NOT SHOW ISSUES RELATED TO THE COMPLAINT.

    Additional Manufacturer Narrative · 0

    QN#(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 OF THE RETURNED SAMPLE REVEALED THAT THE FIRST TWO STAPLES APPEARED MISALIGNED. THE STAPLER WAS RETURNED WITH 39 STAPLES REMAINING IN THE COVER BLOCK. THE TRIGGER WAS RETURNED PARTIALLY 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, NO STAPLE WAS FIRED. MULTIPLE ATTEMPTS WERE MADE, BUT NO STAPLES FIRED. IT APPEARED THAT THE MISALIGNMENT OF THE FIRST TWO STAPLES PREVENTED THE STAPLES FROM MOVING DOWN THE TRACK AND INTO THE FORMING TOOL. THE STAPLER WAS DISASSEMBLED, AND IT WAS CONFIRMED TO HAVE BEEN ASSEMBLED CORRECTLY. MANUAL REALIGNMENT OF THE STAPLES WAS ATTEMPTED; HOWEVER, THE STAPLER STILL COULD NOT FIRE STAPLES CORRECTLY. EXCESSIVE BIOLOGICAL MATERIAL WAS OBSERVED IN THE DEVICE, BUT NO OTHER DEFECTS OR ANOMALIES WERE OBSERVED. 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." THE REPORTED COMPLAINT OF "MISFIRE/JAMMING-MULTIPLE STAPLES FIRING" WAS CONFIRMED BASED UPON THE SAMPLE RECEIVED. VISUAL EXAMINATION REVEALED THAT THE FIRST TWO STAPLES APPEARED TO BE MISALIGNED. UPON FUNCTIONAL INSPECTION, THE MISALIGNMENT OF THE FIRST TWO STAPLES PREVENTED THE REMAINING STAPLES FROM FIRING. THE SAMPLE WAS DISASSEMBLED, AND NO DEFECTS OR ANOMALIES WERE OBSERVED. 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 & 73B2200012.

    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 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
    1704867 VISISTAT 35R 6/BOX STAPLE, REMOVABLE (SKIN) QQS TELEFLEX MEDICAL IPN028492 73B2200012 14026704631770

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown