BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIAL EDGE BIOPSY FORCEP

    MDR report key: 38792 · Received September 11, 1996

    Report

    Report Number
    38792
    Event Type
    Other
    Date Received
    September 11, 1996
    Date of Event
    July 31, 1996
    Report Date
    September 10, 1996
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    BSP
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NEW RADIAL EDGE BIOPSY FORCEP USED DURING BRONCHOSCOPY. FORCEP TOOK LARGER SPECIMEN THAN PREVIOUS FORCEP USED BY THE PHYSICIAN. PT HAD PNEUMOTHORAX POST PROCEDURE. PHYSICIAN ASKED NURSE TO CALL MFR AND INSTRUMENT WAS RETURNED TO THEM. SO, THE LOT # AND EXPIRATION DATE ARE UNKNOWN. THE WRITER OF THIS REPORT WAS NOT NOTIFIED OF THE OCCURRENCE UNTIL A LETTER WAS RECEIVED FROM THE MFR ON 8/28/96.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL EDGE BIOPSY FORCEP BIOPSY FORCEP BSP BOSTON SCIENTIFIC CORP. NONE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other