BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENCOR ENSPIRE BREAST BIOPSY SYSTEM

    MDR report key: 10867656 · Received November 19, 2020

    Report

    Report Number
    2020394-2020-20450
    Event Type
    Malfunction
    Date Received
    November 19, 2020
    Date of Event
    October 22, 2020
    Report Date
    June 1, 2021
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    UDI-DI
    00801741086113
    PMA / PMN Number
    K111100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING REVIEW: THE EVENT WAS DETERMINED TO BE EXPECTED AND THE INVESTIGATION DID NOT IDENTIFY ANY MANUFACTURING AND/OR SERVICE-RELATED ISSUES, THEREFORE A DEVICE HISTORY RECORD AND A MANUFACTURING REVIEW ARE NOT REQUIRED. INVESTIGATION SUMMARY: THE DEVICE WAS RECEIVED FOR EVALUATION. THE ENSPIRE WAS VISUALLY EXAMINED UPON RECEIPT AND WAS FOUND TO BE FREE OF PHYSICAL DAMAGE. THE DEVICE WAS TESTED AND INVESTIGATION HAS BEEN DETERMINED TO BE UNCONFIRMED FOR THE REPORTED EQUIPMENT NEEDLE SPONTANEOUSLY ACTIVATES AS THE ENSPIRE DIDN¿T PRESENT PROBLEMS. THE ROOT CAUSE CANNOT BE DETERMINED AS THE PROBLEM COULD NOT BE REPRODUCED. LABELING REVIEW: THE REVIEW OF THE INSTRUCTIONS FOR USE, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, AND CONTRAINDICATIONS SHOWED THAT THE PRODUCT LABELING IS ADEQUATE. (EXPIRY DATE: 03/2045), (METHOD, RESULT, CONCLUSION). 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

    H10: MANUFACTURING REVIEW: AS THE DEVICE WAS NOT RETURNED, AND NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED, A DEVICE HISTORY RECORD REVIEW AND A MANUFACTURING REVIEWS ARE NOT REQUIRED. INVESTIGATION SUMMARY: THE DEVICE WAS NOT RETURNED FOR EVALUATION. AS THE EVALUATION COULD NOT BE PERFORMED, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED EVENT. THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION. LABELING REVIEW: THE REVIEW OF THE INSTRUCTIONS FOR USE, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, AND CONTRAINDICATIONS SHOWED THAT THE PRODUCT LABELING IS ADEQUATE. H10: D4 (EXPIRY DATE: 03/2045). 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 THE EQUIPMENT NEEDLE SPONTANEOUSLY ACTIVATES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE EQUIPMENT NEEDLE SPONTANEOUSLY ACTIVATES.

    Additional Manufacturer Narrative · 1

    AS THE SERIAL NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORD IS CURRENTLY BEING PERFORMED. THE RETURN OF THE SAMPLE IS PENDING. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. (EXPIRY DATE: 03/2045).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EQUIPMENT NEEDLE SPONTANEOUSLY ACTIVATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1333399 ENCOR ENSPIRE BREAST BIOPSY SYSTEM BIOPSY INSTRUMENT KNW BARD PERIPHERAL VASCULAR, INC. E4115 00801741086113

    Patients

    Seq Age Sex Outcome Treatment
    1 Other