BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISISTAT 35R 6/BOX

    MDR report key: 14525257 · Received May 27, 2022

    Report

    Report Number
    3003898360-2022-00209
    Event Type
    Malfunction
    Date Received
    May 27, 2022
    Date of Event
    May 2, 2022
    Report Date
    May 25, 2022
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    QQS
    UDI-DI
    14026704631770
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    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 35R 6/BOX LOT # 73A2200356 WAS MANUFACTURED ON 01/11/2022 A TOTAL OF (B)(4) PIECES. LOT WAS RELEASED ON 01/25/2022. DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. P/N 528135 IS NOT BEING MANUFACTURED CURRENTLY, HOWEVER, ANOTHER PART NUMBER FROM THE SAME FAMILY WAS USE FOR THE "VERIFICATION OF FAILURE MODE REPORTED IN THE CURRENT MANUFACTURING PROCESS" AND WAS CONDUCTED AS FOLLOWS: 13 STAPLERS WERE TAKEN FROM THE CURRENT PRODUCTION FROM P/N 528236 VISISTAT 35W NON-STERILE LOT# 73E2200856 THE STAPLERS WERE FUNCTIONALLY INSPECTED 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. CORRECTIVE ACTIONS CANNOT BE ESTABLISHED SINCE IT IS NECESSARY TO RECEIVE THE PHYSICAL SAMPLE TO PERFORM A PROPER INVESTIGATION AND CONFIRM THE ALLEGED DEFECT. AT THIS TIME DUE THE SAMPLE IS NOT AVAILABLE IS NOT POSSIBLE TO DETERMINE THE SOURCE OF THE DEFECT REPORTED. CUSTOMER COMPLAINT CANNOT BE CONFIRMED DUE THE PRODUCT SAMPLE IS NOT AVAILABLE TO PERFORM A PROPER INVESTIGATION AND DETERMINATE THE ROOT CAUSE.

    Description of Event or Problem · 0

    WE ARE HAVING ISSUES WITH THE STAPLER UNLOADING TOO AND THEN NOT WORKING. FOUR TO FIVE STAPLERS DID NOT WORK: NOT DEPLOYING A STAPLE OR NOT BENDING THE STAPLE INTO THE SKIN.

    Description of Event or Problem · 0

    WE ARE HAVING ISSUES WITH THE STAPLER UNLOADING TOO AND THEN NOT WORKING. FOUR TO FIVE STAPLERS DID NOT WORK: NOT DEPLOYING A STAPLE OR NOT BENDING THE STAPLE INTO THE SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2202222 VISISTAT 35R 6/BOX STAPLE, REMOVABLE (SKIN) QQS TELEFLEX MEDICAL IPN028492 73A2200356 14026704631770

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown