BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE ENDO CLIP L 10MM

    MDR report key: 140648 · Received December 23, 1997

    Report

    Report Number
    1219930-1997-02762
    Event Type
    Malfunction
    Date Received
    December 23, 1997
    Date of Event
    November 24, 1997
    Report Date
    December 1, 1997
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    1/21/1998-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA.

    Description of Event or Problem · 1

    REPORTEDLY, THE CLIPS DID NOT ADVANCE PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE ENDO CLIP L 10MM DISPOSABLE CLIP APPLIER GCJ UNITED STATES SURGICAL CORP. NA N7J157

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN