BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPSYS MARKER CLIP WITH INTRODUCER

    MDR report key: 202504 · Received December 15, 1998

    Report

    Report Number
    1527736-1998-04179
    Event Type
    Malfunction
    Date Received
    December 15, 1998
    Date of Event
    December 3, 1998
    Report Date
    December 3, 1998
    Manufacturer
    BIOPSYS MEDICAL, INC.
    Product Code
    KNW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE REP THAT THE DEVICE WAS USED DURING STEREOTACTIC BREAST BIOPSY. IT WAS REPORTED THE METAL TIP OF THE MICROMARK CLIP APPLIER DETACHED FROM THE APPLIER UPON REMOVAL FROM THE PATIENT. THE SURGEON STATED THAT SHE WAS UNABLE TO RETRACT THE TIP INTO THE CANNULA PRIOR TO REMOVAL BECAUSE IT WAS CAUGHT ON THE EDGE OF THE NOTCH IN THE CANNULA. THE TIP OF THE APPLIER WAS LEFT IN THE PATIENT. THERE WAS NO CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPSYS MARKER CLIP WITH INTRODUCER BIOPSYS KNW BIOPSYS MEDICAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other