BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE VERSAPORT 5MM-12MM SLEEVE

    MDR report key: 118286 · Received September 3, 1997

    Report

    Report Number
    1219930-1997-01951
    Event Type
    Malfunction
    Date Received
    September 3, 1997
    Report Date
    August 6, 1997
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE INSTRUMENT WAS LEAKING PNEUMOPERITONEUM. THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE WITHOUT PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE VERSAPORT 5MM-12MM SLEEVE DISPOSABLE SURGICAL TROCAR GCJ UNITED STATES SURGICAL CORP. NA N7C37L

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN