BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENCOR FOOT PEDAL

    MDR report key: 16483387 · Received March 4, 2023

    Report

    Report Number
    2020394-2023-00137
    Event Type
    Malfunction
    Date Received
    March 4, 2023
    Date of Event
    February 6, 2023
    Report Date
    February 23, 2023
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    UDI-DI
    00801741086557
    PMA / PMN Number
    K013641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING REVIEW: A DEVICE HISTORY RECORD 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 FOOT PEDAL WAS RECEIVED AT THE BARD MEDICAL SOUTH AFRICA. THE ENCOR FOOT PEDAL WAS VISUALLY INSPECTED UPON RECEIPT AND WAS FOUND TO BE FREE FROM DEFECTS AND ALL LABELING IS LEGIBLE. THE DEVICE WAS FUNCTIONALLY TESTED AND PASSED ALL THE TESTS DURING EVALUATION. NO OTHER ANOMALIES WERE IDENTIFIED. THEREFORE, THE INVESTIGATION IS DETERMINED TO BE UNCONFIRMED FOR THE REPORTED SYSTEM TOOK TWO FURTHER SAMPLES WITHOUT PRESSING/SELECTING ANYTHING ON THE ENCOR FOOT PEDAL. THE ROOT CAUSE FOR THE REPORTED SYSTEM TOOK TWO FURTHER SAMPLES WITHOUT PRESSING/SELECTING ANYTHING ON THE ENCOR FOOT PEDAL 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. (EXPIRY DATE: 12/2050).

    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
    516274 ENCOR FOOT PEDAL REUSABLE BIOPSY KNW BARD PERIPHERAL VASCULAR, INC. FSENCOR01 00801741086557

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown