BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENCOR ENSPIRE SYSTEM

    MDR report key: 21888163 · Received April 23, 2025

    Report

    Report Number
    2020394-2025-00608
    Event Type
    Malfunction
    Date Received
    April 23, 2025
    Date of Event
    March 26, 2025
    Report Date
    June 20, 2025
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    UDI-DI
    00801741086137
    PMA / PMN Number
    K111100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: AS THE SERIAL NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Additional Manufacturer Narrative · 0

    H11: MANUFACTURING REVIEW: A DHR AND MANUFACTURING REVIEW WAS NOT REQUIRED AS THE EVENT WAS DETERMINED TO BE EXPECTED, AND THE INVESTIGATION DID NOT IDENTIFY ANY MANUFACTURING AND/OR SERVICE-RELATED ISSUES. INVESTIGATION SUMMARY: THE ENCOR ULTRA SERIAL NUMBER (B)(6) WAS RECEIVED AT THE MEDICON INC. THE ENCOR ULTRA WAS VISUALLY INSPECTED UPON RECEIPT AND NO PHYSICAL DAMAGE WAS FOUND TO THE UNIT. THE DEVICE WAS FUNCTIONALLY TESTED AND PASSED THE TESTS DURING EVALUATION. NO OTHER ANOMALIES WERE IDENTIFIED. THEREFORE, THE INVESTIGATION IS DETERMINED TO BE UNCONFIRMED FOR THE REPORTED DEVICE SAMPLING ON ITS OWN ISSUE. THE ROOT CAUSE FOR REPORTED DEVICE SAMPLING ON ITS OWN ISSUE CANNOT BE DETERMINED AS THE PROBLEM COULD NOT BE REPRODUCED. LABELING REVIEW: THE LABELING/PACKAGING REVIEW WAS NOT REQUIRED AS THE REPORTED EVENT IS NOT ASSOCIATED WITH A LABELING, PACKAGING, OR USE RELATED ISSUE. G3, H3, H6 (METHOD, RESULT, CONCLUSION). SECTION A THROUGH F ¿ THE INFORMATION PROVIDE BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SAMPLING WAS CONDUCTED WITHOUT PUSHING SAMPLE BUTTON. REPLACED A PROBE WITH ANOTHER, AND PROCEDURE WAS COMPLETED. IT WAS FURTHER REPORTED THAT THE ISSUE OCCURRED DURING SAMPLING. WHEN THE OPENER WAS CLOSED, DISCONNECTED THE NEEDLE AND REPLACED WITH ANOTHER NEEDLE. THEN PROCEDURE WAS COMPLETED. NO ERROR MESSAGES WERE DISPLAYED. A PATIENT WAS INVOLVED, HOWEVER THERE WAS NO INJURY REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SAMPLING WAS CONDUCTED WITHOUT PUSHING SAMPLE BUTTON. REPLACED A PROBE WITH ANOTHER, AND PROCEDURE WAS COMPLETED. IT WAS FURTHER REPORTED THAT THE ISSUE OCCURRED DURING SAMPLING. WHEN THE OPENER WAS CLOSED, DISCONNECTED THE NEEDLE AND REPLACED WITH ANOTHER NEEDLE. THEN PROCEDURE WAS COMPLETED. NO ERROR MESSAGES WERE DISPLAYED. A PATIENT WAS INVOLVED, HOWEVER THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675187 ENCOR ENSPIRE SYSTEM BIOPSY INSTRUMENT KNW BARD PERIPHERAL VASCULAR, INC. 00801741086137

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown