BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPSYS 11G DISPOSABLE PROBE

    MDR report key: 201179 · Received December 10, 1998

    Report

    Report Number
    1527736-1998-04019
    Event Type
    Injury
    Date Received
    December 10, 1998
    Date of Event
    November 11, 1998
    Report Date
    November 11, 1998
    Manufacturer
    BIOPSYS MEDICAL ,INC
    Product Code
    KNW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS USED DURING A BREAST BIOPSY. IT WAS REPORTED THE CASE WAS SET UP WITH A PROBE AND THE PACKAGE READ 11 GAUGE P1155 BUT THE ACTUAL DEVICE ENDED UP BEING A 14 GAUGE PROBE. THE PHYSICIAN USED THE 14 GAUGE PROBE TO COMPLETE THE CASE. THE PHYSICIAN DIDN'T TAKE AS MANY SPECIMENS (TOOK HALF THE AMOUNT OF SPECIMENS HE USUALLY TAKES) AS HE KNEW HE COULDN'T PLACE A CLIP. HE IS HOPING HE GOT ENOUGH SPECIMENS TO MAKE A DIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPSYS 11G DISPOSABLE PROBE BIOPSYS KNW BIOPSYS MEDICAL ,INC NA W6528

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention