BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE ENDO CLIP II M/L

    MDR report key: 124322 · Received September 29, 1997

    Report

    Report Number
    1219930-1997-02145
    Event Type
    Malfunction
    Date Received
    September 29, 1997
    Report Date
    September 4, 1997
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    12/15/1997-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA.

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE INSTRUMENT JAMMED. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE ENDO CLIP II M/L DISPOSABLE CLIP APPLIER GCJ UNITED STATES SURGICAL CORP. NA N7D186

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN