BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE MULTIFIRE ENDO GIA 45-3.5 DISPOSABLE LOADING UNI

    MDR report key: 118331 · Received September 3, 1997

    Report

    Report Number
    1219161-1997-01148
    Event Type
    Malfunction
    Date Received
    September 3, 1997
    Date of Event
    June 20, 1997
    Report Date
    June 20, 1997
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    12/19/97-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA.

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A COLECTOMY UNDER COELIO PROCEDURE. REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY. THE SURGEON APPLIED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED NO PT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE MULTIFIRE ENDO GIA 45-3.5 DISPOSABLE LOADING UNI DISPOSABLE SURGICAL STAPLER GCJ UNITED STATES SURGICAL CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN