BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEP

    MDR report key: 107120 · Received July 21, 1997

    Report

    Report Number
    1721520-1997-00001
    Event Type
    Malfunction
    Date Received
    July 21, 1997
    Date of Event
    July 6, 1997
    Report Date
    July 21, 1997
    Manufacturer
    INNERDYNE, INC.
    Product Code
    GEA
    Removal / Correction Number
    900348
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON FRIDAY, 18 JULY 1997, INFO WAS RECEIVED. THE EPISODE OCCURRED AT HOSP. DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. DURING THE PROCEDURE, THE RADIALLY EXPANDING DILATION ACCESS PRODUCT WAS PLACED WITHOUT INCIDENT TO ESTABLISH A WORKING CHANNEL INTO THE ABDOMEN. ANOTHER SURGICAL INSTRUMENT WAS PLACED INTO THE WORKING CHANNEL, DURING WHICH AN INADVERTENT PENETRATION THROUGH THE STOP DUCKBILL VALVE OCCURRED. A SMALL PIECE OF MATERIAL (RUBBER) WAS NOTICED IN THE PT WHICH WAS SUCCESSFULLY RETRIEVED FROM THE PT WITHOUT INCIDENT. THE CANNULA WAS REMOVED AND REPLACED WITH A NEW S101010 CANNULA. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AS INTENDED, NO HARM OR INJURY TO THE PT WAS NOTED, AND THE PT HAS HAD A ROUTINE POST-OPERATIVE RECOVERY AND COURSE. THE REPORTED EVENT IS DESCRIBED AS A USER RELATED EVENT, OCCURRING AT FIRST USAGE OF THE PRODUCT, DUE TO UNFAMILIARITY OF PLACING SHARP SECONDARY SURGICAL INSTRUMENTS THROUGH THE WORKING CHANNEL. THIS INCIDENT REPRESENTS THE FIRST REPORTS OF THIS TYPE OF EVENT WITH THE REPOSABLE STEP SYSTEM, AND ARE BELIEVED TO BE USER RELATED EVENTS. THE PRODUCT WAS RETURNED TO INNERDYNE, INC., FOR EVALUATION WHICH HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEP PERCUTANEOUS SHEATH WITH DILATOR GEA INNERDYNE, INC. NA GE14074

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN