BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISISTAT 35R 6/BOX

    MDR report key: 14788614 · Received June 23, 2022

    Report

    Report Number
    3003898360-2022-00261
    Event Type
    Malfunction
    Date Received
    June 23, 2022
    Date of Event
    June 16, 2022
    Report Date
    June 16, 2022
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    QQS
    UDI-DI
    14026704631770
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE HISTORY REVIEW FOR THE PRODUCT VISISTAT 35R 6/BOX LOT# 73B2200288 INVESTIGATION DID NOT SHOW ISSUES RELATED TO THE COMPLAINT.

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED FOUR UNOPENED REPRESENTATIVE SAMPLES OF 528135 VISISTAT 35R 6/BOX FOR INVESTIGATION. THE SAME FOUR UNITS WERE RETURNED FOR BOTH TC#1900093876 AND TC#1900093877. THE PACKAGING OF TWO STAPLERS WAS OBSERVED TO BE BROKEN. A NONCONFORMANCE HAS BEEN OPENED TO FURTHER INVESTIGATE THE BROKEN PACKAGING ISSUE. THE PACKAGING DEFECT IS UNRELATED TO THE DEFECT OF "MISFIRE/JAMMING - STAPLES NOT FIRING" REPORTED BY THE CUSTOMER. INITIAL VISUAL EXAMINATION OF ALL FOUR RETURNED SAMPLES REVEALED THAT THE STAPLES APPEARED PROPERLY ALIGNED. 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 MISALIGNMENT ISSUE WAS PRESENT AT THE TIME OF ASSEMBLY. IT COULD NOT BE DETERMINED WHAT CAUSED THE STAPLES TO MISALIGN. IN SUMMARY, THE REPORTED COMPLAINT OF "MISFIRE/JAMMING - STAPLES NOT FIRING" WAS CONFIRMED BASED UPON THE THIRD OF FOUR REPRESENTATIVE SAMPLES RECEIVED. VISUAL EXAMINATION REVEALED THAT THE STAPLES BECAME MISALIGNED. UPON FUNCTIONAL INSPECTION, THE MISALIGNMENT PREVENTED THE REMAINING STAPLES FROM FIRING CONSISTENTLY. THE SAMPLE WAS SHIPPED TO THE MANUFACTURING SITE FOR FURTHER EVALUATION. AT THE MANUFACTURING SITE, THE DEFECT WAS CONFIRMED. 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 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

    WE FACED 2 TYPES OF ISSUES WITH THE STAPLERS: STAPLES NOT FIRED, STAPLES NOT CLOSING.

    Description of Event or Problem · 0

    WE FACED 2 TYPES OF ISSUES WITH THE STAPLERS: STAPLES NOT FIRED, STAPLES NOT CLOSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277475 VISISTAT 35R 6/BOX STAPLE, REMOVABLE (SKIN) QQS TELEFLEX MEDICAL IPN028492 73B2200288 14026704631770

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown