BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEP

    MDR report key: 107893 · Received July 25, 1997

    Report

    Report Number
    1721520-1997-00002
    Event Type
    Malfunction
    Date Received
    July 25, 1997
    Date of Event
    June 20, 1997
    Report Date
    July 25, 1997
    Manufacturer
    INNERDYNE, INC.
    Product Code
    GCJ
    Removal / Correction Number
    900356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON WEDNESDAY, 23 JULY 1997, INFO WAS RECEIVED BY THE INNERDYNE. REGULATORY AFFAIRS DEPT INDEPENDENT SALES REP, REGARDING ONE (1) INCIDENT. THE EPISODE OCCURRED AT MEDICAL CENTER, DURING A SURGICAL PROCEDURE UNDER THE DIREACTION OF DR. ON 20 JUNE 1997. DURING THE PROCEDURE, THE RADIALLY EXPANDING DILATATION ACCESS PRODUCT WAS PLACED WITHOUT INCIDENT TO ESTABLISH A WORKING CHANNEL INTO THE PT. ANOTHER SURGICAL INSTRUMENT WAS PLACED THROUGH. THE WORKING CHANNEL, AN ETHICON ENDO-GIA INSTRUMENT, WAS PLACED. UPON REMOVAL OF THE ENDO GIA, A SUBSTANTIAL INSUFFLATION LEAK WAS OBSERVED BY THE DR. THE PROCEDURE IS BELIEVED TO HAVE BEEN COMPLETED WIHOUT FURTHER INCIDENT AND THE PT RETURNED TO THE RECOVERY AREA. POST-SURGICAL INSPECTION OF THE ACCESS DEVICE BY THE SIRGICAL TEAM REVEALED A PERFORATION OF THE INTERNAL DUCKBILL VALVE. A SMALL PIECE OF DUCKBILL VALVE MATERIAL (RUBBER), APPROX 4MM X 4MM, HAD BEEN TORN FROM THE VALVE COMPONENT. THE REPORTED EVENT IS DESCRIBED AS A USER AND PROCEDURAL RELATED EPISODE. THE PRODUCT WAS RETURNED TO INNERDYNE, INC. FOR EVAL WHICH HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEP PERCUTANEOUS SHEATH WITH DILATOR GCJ INNERDYNE, INC. NA GD15978

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention