BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENCOR ENSPIRE SYSTEM

    MDR report key: 16483384 · Received March 4, 2023

    Report

    Report Number
    2020394-2023-00136
    Event Type
    Malfunction
    Date Received
    March 4, 2023
    Date of Event
    February 6, 2023
    Report Date
    March 6, 2023
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    UDI-DI
    00801741086120
    PMA / PMN Number
    K111100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. (EXPIRATION DATE: 12/2050).

    Additional Manufacturer Narrative · 0

    H10: 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 ENSPIRE SYSTEM WAS RETURNED FOR EVALUATION. THE ENCOR ENSPIRE SYSTEM WAS VISUALLY INSPECTED UPON RECEIPT, AND IT WAS FOUND TO BE IN GOOD CONDITION. 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 UNINTENDED MOVEMENT ISSUE. THE ROOT CAUSE FOR THE REPORTED UNINTENDED MOVEMENT ISSUE CANNOT BE DETERMINED AS THE PROBLEM COULD NOT BE REPRODUCED. LABELING REVIEW: A REVIEW OF PRODUCT LABELING DOCUMENTATION (E.G., PROCEDURAL INSTRUCTIONS, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, CONTRAINDICATIONS, NURSING GUIDE, AND UNIT LABEL) DID NOT FIND ANY PRODUCT LABELING INADEQUACY. H10: D4 (EXPIRATION DATE: 12/2050), G3, H6 (METHOD). 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, WHILE TRYING TO DEPLOY THE MARKER, THE SYSTEM TOOK TWO FURTHER SAMPLES WITHOUT PRESSING/SELECTING ANYTHING ON THE ENCOR SYSTEM, DRIVER OR FOOT PEDAL. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, WHILE TRYING TO DEPLOY THE MARKER, THE SYSTEM TOOK TWO FURTHER SAMPLES WITHOUT PRESSING/SELECTING ANYTHING ON THE ENCOR SYSTEM, DRIVER OR FOOT PEDAL. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515492 ENCOR ENSPIRE SYSTEM REUSABLE BIOPSY KNW BARD PERIPHERAL VASCULAR, INC. 00801741086120

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown