BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSUTURE

    MDR report key: 195984 · Received November 5, 1998

    Report

    Report Number
    MW1014916
    Event Type
    Malfunction
    Date Received
    November 5, 1998
    Date of Event
    November 4, 1998
    Manufacturer
    UNITED STATES SURGICAL CORP AUTO SUTURE CO.
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SNARE ON ADVANCED BREAST BIOPSY INSTRUMENTATION SYSTEM DISPOSABLE INSTRUMENT FAILED: DID NOT CUT TISSUE AND WOULD NOT CLOSE. CAUTERY FUNCTION WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSUTURE DISPOSABLE INSTRUMENT KNW UNITED STATES SURGICAL CORP AUTO SUTURE CO. 080003 - 15MM N7K147M

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other