BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE ENDO CLIP 10MM REUSABLE

    MDR report key: 126368 · Received October 8, 1997

    Report

    Report Number
    1219161-1997-01398
    Event Type
    Malfunction
    Date Received
    October 8, 1997
    Report Date
    September 11, 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

    12/03/1997-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA.

    Description of Event or Problem · 1

    THE PRODUCT WAS USED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE CLIPS SCISSORED. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE ENDO CLIP 10MM REUSABLE SURGICAL STAPLING INSTRUMENT GCJ UNITED STATES SURGICAL CORP. 176599 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN