BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE PREMIUM SURGICLIP S-9.0

    MDR report key: 216993 · Received March 29, 1999

    Report

    Report Number
    2647580-1999-00288
    Event Type
    Malfunction
    Date Received
    March 29, 1999
    Date of Event
    February 22, 1999
    Report Date
    March 1, 1999
    Manufacturer
    UNITED STATES SURGICAL CORPORATION
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A CABG PROCEDURE. REPORTEDLY, THE CLIPS DID NOT LOAD PROPERLY. THE HOSPITAL HAS REPORTED NO PATIENT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE PREMIUM SURGICLIP S-9.0 DISPOSABLE CLIP APPLIER GAG UNITED STATES SURGICAL CORPORATION NA P8H03

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN