BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENCOR FOOT PEDAL

    MDR report key: 23954547 · Received January 5, 2026

    Report

    Report Number
    2020394-2025-02301
    Event Type
    Malfunction
    Date Received
    January 5, 2026
    Date of Event
    December 8, 2025
    Report Date
    January 30, 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
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: MANUFACTURING REVIEW: A DHR AND MANUFACTURING REVIEW WAS NOT REQUIRED AS THE SERIAL NUMBER IS UNKNOWN, AND DEVICE WAS NOT RETURNED. INVESTIGATION SUMMARY: THE PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION. NO PHOTOS OR VIDEO WERE PROVIDED FOR REVIEW. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED FAILURE AS NO OBJECTIVE EVIDENCE WAS PROVIDED FOR REVIEW. A DEFINITIVE ROOT CAUSE FOR THE UNINTENDED MOVEMENT ISSUE COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION. LABELING REVIEW: THE LABELLING/PACKAGING REVIEW WAS NOT REQUIRED AS THE REPORTED EVENT IS NOT ASSOCIATED WITH A LABELLING, PACKAGING, OR USE RELATED ISSUE. D2B (GEI; KNW), G3, 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.

    Additional Manufacturer Narrative · 0

    H11: AS THE SERIAL NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE RETURN OF THE SAMPLE IS PENDING. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. D2(GEI; KNW). SECTION A THROUGH F ¿ THE INFORMATION PROVIDED 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 REUSABLE BIOPSY PROCEDURE USING THROUGH THE ENCOR ENSPIRE SYSTEM'S. IT WAS REPORTED THAT DURING A STEREOTACTIC SETUP, THE ENCOR ENSPIRE SYSTEM'S TOUCHSCREEN WAS STICKING ON ONE OF THE SLICES LIKE IT WANTED TO SAMPLE THE SAME AREA TWICE. ADDITIONAL CLARIFICATION WAS RECEIVED STATED THAT THE TOUCHSCREEN WOULDN'T ADVANCE TO THE NEXT SAMPLE LOCATION, EVEN THOUGH MULTIPLE LOCATIONS WERE SELECTED BY THE USER, ONLY THE 12 O'CLOCK POSITION WAS BEING SAMPLED. THE 12 O'CLOCK POSITION WAS SAMPLED TWICE. THE USER KEPT ATTEMPTING TO SELECT THE NEXT SAMPLE LOCATION AND EVENTUALLY WAS ABLE TO COLLECT OTHER TISSUE SAMPLES TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    A PATIENT UNDERWENT A REUSABLE BIOPSY PROCEDURE USING THROUGH THE ENCOR ENSPIRE SYSTEM'S, IT WAS REPORTED THAT DURING A STEREOTACTIC SETUP, THE ENCOR ENSPIRE SYSTEM'S TOUCHSCREEN WAS STICKING ON ONE OF THE SLICES LIKE IT WANTED TO SAMPLE THE SAME AREA TWICE. ADDITIONAL CLARIFICATION WAS RECEIVED STATED THAT THE TOUCHSCREEN WOULDN'T ADVANCE TO THE NEXT SAMPLE LOCATION, EVEN THOUGH MULTIPLE LOCATIONS WERE SELECTED BY THE USER, ONLY THE 12 O'CLOCK POSITION WAS BEING SAMPLED. THE 12 O'CLOCK POSITION WAS SAMPLED TWICE. THE USER KEPT ATTEMPTING TO SELECT THE NEXT SAMPLE LOCATION AND EVENTUALLY WAS ABLE TO COLLECT OTHER TISSUE SAMPLES TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29181 ENCOR FOOT PEDAL REUSABLE BIOPSY KNW BARD PERIPHERAL VASCULAR, INC. 00801741086557

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown