BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENCOR FOOT PEDAL

    MDR report key: 25011202 · Received April 28, 2026

    Report

    Report Number
    2020394-2026-01028
    Event Type
    Malfunction
    Date Received
    April 28, 2026
    Date of Event
    April 2, 2026
    Report Date
    April 21, 2026
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    UDI-DI
    00801741086557
    PMA / PMN Number
    K013641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: AS THE SERIAL NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS CANNOT BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. D2B (GEI; KNW). 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

    A PATIENT UNDERWENT A BIOPSY PROCEDURE USING ENCOR DRIVER. IT WAS REPORTED THAT DURING DEVICE SETUP, THE ENCOR DRIVER WAS REPORTED TO HAVE REPEATEDLY AND UNINTENTIONALLY ACTIVATED ITS CUTTING MECHANISM. THE MODALITY USED DURING SETUP WAS UNKNOWN; THEREFORE, THE EVENT WAS DOCUMENTED UNDER AN ENCOR ENSPIRE SYSTEM (DYEPF015) WITH AN UNKNOWN ENCOR FOOT PEDAL. THERE WAS NO PATIENT INVOLVEMENT. FURTHERMORE, ADDITIONAL DETAILS INDICATED THAT A DIFFERENT NEEDLE WAS USED DURING SUBSEQUENT TESTING, AND THE ISSUE DID NOT REOCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1072864 ENCOR FOOT PEDAL REUSABLE BIOPSY KNW BARD PERIPHERAL VASCULAR, INC. 00801741086557

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown