BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISISTAT 35W 6/BOX

    MDR report key: 14578396 · Received June 2, 2022

    Report

    Report Number
    3003898360-2022-00244
    Event Type
    Malfunction
    Date Received
    June 2, 2022
    Date of Event
    June 2, 2022
    Report Date
    June 2, 2022
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    QQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    (B)(4). PER DHR THE PRODUCT VISISTAT 35W 6/BOX LOT # 73F2100952 WAS MANUFACTURED ON 06/29/2021 A TOTAL OF (B)(4) PIECES. LOT WAS RELEASED ON 07/08/2021. DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. FROM THE PICTURES ATTACHED WAS UNABLE TO BE CONFIRMED FAILURE MODE REPORTED AS "MISFIRE/JAMMING - INFO NOT PROVIDED". HOWEVER , IT IS NECESSARY TO RECEIVE THE PHYSICAL SAMPLE TO PERFORM A PROPER INVESTIGATION, DETERMINE ROOT CAUSE & IMPLEMENT CORRECTIVE ACTIONS. A VERIFICATION OF FAILURE MODE REPORTED IN THE CURRENT MANUFACTURING PROCESS WAS CONDUCTED AS FOLLOWS: 13 STAPLERS WERE TAKEN FROM THE CURRENT PRODUCTION FROM P/N 528235 VISISTAT 35W 6/BOX LOT# 73E2200554 THE STAPLERS WERE FUNCTIONALLY INSPECTED (FIRED) AND ISSUE REPORTED "MISFIRE/JAMMING - INFO NOT PROVIDED" WAS NOT OBSERVED IN THE CURRENT MANUFACTURING PROCESS, THE STAPLES WERE LOADED AND RELEASED CORRECTLY. REVISION OF FMEA-08-028-REV 05 WAS PERFORMED AND THE FAILURE MODE IS ALREADY INCLUDING IT, NO UPDATE IS REQUIRED. FAILURE MODE "MISFIRE/JAMMING - INFO NOT PROVIDED" COULD NOT BE CONFIRMED WITH PICTURE ATTACHED, HOWEVER IT IS NECESSARY TO RECEIVE THE PHYSICAL SAMPLE TO PERFORM A PROPER INVESTIGATION, DETERMINE ROOT CAUSE & IMPLEMENT CORRECTIVE ACTIONS. FAILURE MODE "MISFIRE/JAMMING - INFO NOT PROVIDED" COULD NOT BE CONFIRMED WITH PICTURE. HOWEVER , IT IS NECESSARY TO RECEIVE THE PHYSICAL SAMPLE TO PERFORM A PROPER INVESTIGATION, DETERMINATE THE ROOT CAUSE & CORRECTIVE ACTIONS.

    Description of Event or Problem · 0

    STAPLE JAMMING.

    Description of Event or Problem · 0

    STAPLE JAMMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154116 VISISTAT 35W 6/BOX STAPLE, REMOVABLE (SKIN) QQS TELEFLEX MEDICAL 73F2100952

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown