BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE ENDO CLIP 5MM

    MDR report key: 150538 · Received February 20, 1998

    Report

    Report Number
    1219161-1998-00335
    Event Type
    Malfunction
    Date Received
    February 20, 1998
    Date of Event
    January 25, 1998
    Report Date
    January 25, 1998
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PRODUCT WAS USED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE CLIPS DID NOT LOAD PROPERLY. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE ENDO CLIP 5MM DISPOSABLE CLIP APPLIER GCJ UNITED STATES SURGICAL CORP. NA U7G116

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN