BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISISTAT 35R 6/BOX

    MDR report key: 16614135 · Received March 24, 2023

    Report

    Report Number
    3003898360-2023-00395
    Event Type
    Malfunction
    Date Received
    March 24, 2023
    Date of Event
    February 17, 2023
    Report Date
    February 27, 2023
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    QQS
    UDI-DI
    14026704631770
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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 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, THE FIRST STAPLE DID NOT FORM PROPERLY. THE NEXT FIVE STAPLES FIRED PROPERLY. TO SIMULATE INSERTION INTO THE SKIN, THE REMAINING STAPLES WERE FIRED INTO A SIMULATED SKIN PAD. ONE OF THESE STAPLES MISFIRED. THE STAPLER WAS DISASSEMBLED, AND IT WAS CONFIRMED TO HAVE BEEN ASSEMBLED CORRECTLY. DIE CASTING ANOMALIES WERE DISCOVERED ON THE FORMING TOOL. NO OTHER DEFECTS OR ANOMALIES WERE OBSERVED WITH THE DEVICE. IT APPEARED THAT THE STAPLE MISALIGNMENT PREVENTED THE REMAINING STAPLES FROM MOVING DOWN THE TRACK AND FIRING CORRECTLY. IT COULD NOT BE DETERMINED WHAT EXACTLY CAUSED THE STAPLES TO MISALIGN. ALTHOUGH A LOT NUMBER WAS NOT REPORTED, A POTENTIAL LOT NUMBER WAS FOUND THROUGH THE SALES HISTORY. THE POTENTIAL LOT NUMBER IS 73C 2200521. PER DHR THE PRODUCT VISISTAT 35R 6/BOX LOT # 73C2200521 WAS MANUFACTURED ON 03/15/2022 A TOTAL OF 10,020 PIECES. LOT WAS RELEASED ON 03/31/2022. DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. THE IFU FOR THIS PRODUCT, L02644 REV. 02, 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. THE REPORTED COMPLAINT OF MISFIRE/JAMMING - STAPLES NOT 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 STAPLES PREVENTED THE REMAINING STAPLES FROM FIRING CORRECTLY. THE SAMPLE WAS DISASSEMBLED, AND DIE CASTING ANOMALIES ON THE FORMING TOOL WAS DISCOVERED. NO OTHER 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. IT COULD NOT BE CONCLUSIVELY DETERMINED WHAT CAUSED THE STAPLES TO MISALIGN. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE DEVICE HISTORY REVIEW FOR THE PRODUCT VISISTAT 35R 6/BOX LOT# 73C2200521 INVESTIGATION DID NOT SHOW ISSUES RELATED TO THE COMPLAINT. THE DEVICE INVESTIGATION IS PENDING AND THE RESULTS WILL BE SUBMITTED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 0

    REPORTED ISSUE: THE DOCTOR FAILED TO FIRE STAPLE FROM DEVICE WHILE USING IT ON A PATIENT.

    Description of Event or Problem · 0

    REPORTED ISSUE: THE DOCTOR FAILED TO FIRE STAPLE FROM DEVICE WHILE USING IT ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583376 VISISTAT 35R 6/BOX STAPLE, REMOVABLE (SKIN) QQS TELEFLEX MEDICAL IPN028492 14026704631770

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown