BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISISTAT 35R 6/BOX

    MDR report key: 14687060 · Received June 14, 2022

    Report

    Report Number
    3003898360-2022-00254
    Event Type
    Malfunction
    Date Received
    June 14, 2022
    Date of Event
    June 7, 2022
    Report Date
    June 13, 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

    QN#: (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    (B)(4). PER DHR THE PRODUCT VISISTAT 35R 6/BOX LOT # 73A2200765 WAS MANUFACTURED ON 01/25/2022 A TOTAL OF (B)(4) PIECES. LOT WAS RELEASED ON 02/08/2022. DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. THE CUSTOMER RETURNED ONE UNOPENED REPRESENTATIVE SAMPLE OF 528135 VISISTAT 35R 6/BOX FOR INVESTIGATION. THE ACTUAL SAMPLE WAS NOT R ETURNED. THE PACKAGING WAS OBSERVED TO BE BROKEN. NC (B)(4) HAS BEEN OPENED TO FURTHER INVESTIGATE THIS ISSUE. THE PACKAGING DEFECT IS UNRELATED TO THE DEFECT OF "MISFIRE/JAM-STAPLES NOT FORMING/CLOSING" REPORTED BY THE CUSTOMER. THE REPRESENTATIVE SAMPLE WAS VISUALLY EXAMINED WITH AND WITHOUT MAGNIFICATION. VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE SAMPLE APPEARS TYPICAL. NO DEFECTS OR ANOMALIES WERE OBSERVED. FUNCTIONAL INSPECTION WAS PERFORMED BY ATTEMPTING TO FIRE STAPLES FROM THE RETURNED STAPLER. THE TRIGGER WAS ENGAGED. UPON FULL ENGAGEMENT OF THE TRIGGER, THE FIRST STAPLE WAS RELEASED. THE NEXT STAPLE WAS RELEASED BUT DID NOT FORM COMPLETELY DUE TO OPERATOR ERROR. THE FOLLOWING TWO STAPLES FORMED PROPERLY. TO SIMULATE INSERTION INTO THE SKIN, THE STAPLER WAS FIRED INTO A SIMULATED SKIN PAD. ALL REMAINING STAPLES WERE FIRED AND WERE ABLE TO ENGAGE AND CLOSE INTO THE SIMULATED SKIN WITH NO DIFFICULTY. THE STAPLER WAS RETURNED WITH 42 STAPLES IN THE CARTRIDGE. 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" AND "STAPLER RELEASES STAPLES FREELY WITHOUT MANUAL ADJUSTMENT TO DISENGAGE STAPLES." A CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME, AS THE ACTUAL SAMPLE WAS NOT RETURNED AND THERE WERE NO FUNCTIONAL ISSUES FOUND WITH THE REPRESENTATIVE SAMPLE. THE REPORTED COMPLAINT OF "MISFIRE/JAM-STAPLES NOT FIRING" COULD NOT BE CONFIRMED SINCE THE ACTUAL SAMPLE WAS NOT RETURNED. ONE REPRESENTATIVE SAMPLE WAS RETURNED IN PLACE OF THE ACTUAL SAMPLE THAT RESULTED IN THE COMPLAINT ISSUE. UPON FUNCTIONAL INSPECTION, NO FUNCTIONAL ISSUES WERE OBSERVED WITH THE RETURNED STAPLER. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE DEVICE WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. THE PROBABLE CAUSE OF THIS COMPLAINT ISSUE COULD NOT BE DETERMINED BASED UPON THE INFORMATION PROVIDED AND WITHOUT THE ACTUAL SAMPLE. NO FURTHER ACTION WILL BE TAKEN AT THIS TIME. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 0

    SEVERAL TEAMS IN THE SURGERY ROOM REPORTED THAT STAPLES DO NOT CLOSE PROPERLY. THEY DO NOT HOLD PROPERLY ON THE PATIENT. 3 INCIDENTS (3 DIFFERENT STAPLERS) HAPPENED ON (B)(6) 2022. INTERVENTIONS WERE FOR KNEE PROSTHESES AND HIP PROSTHESES. NO STAPLE FELL INTO PATIENT. THE SURGEON REMOVED THEM AND REPLACED.

    Description of Event or Problem · 0

    SEVERAL TEAMS IN THE SURGERY ROOM REPORTED THAT STAPLES DO NOT CLOSE PROPERLY. THEY DO NOT HOLD PROPERLY ON THE PATIENT. 3 INCIDENTS (3 DIFFERENT STAPLERS) HAPPENED ON 07 JUNE 2022. INTERVENTIONS WERE FOR KNEE PROSTHESES AND HIP PROSTHESES. NO STAPLE FELL INTO PATIENT. THE SURGEON REMOVED THEM AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1687011 VISISTAT 35R 6/BOX STAPLE, REMOVABLE (SKIN) QQS TELEFLEX MEDICAL IPN028492 73A2200765 14026704631770

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention N/A.