BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSUFFLATION & ACCESS NEEDLE

    MDR report key: 238124 · Received September 1, 1999

    Report

    Report Number
    1721520-1999-00008
    Event Type
    Injury
    Date Received
    September 1, 1999
    Date of Event
    August 27, 1999
    Report Date
    August 31, 1999
    Manufacturer
    INNERDYNE, INC.
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON FRIDAY, AUGUST 27, 1999, PRELIMINARY INFO WAS RECEIVED BY THE INNERDYNE QUALITY COMPLIANCE DEPARTMENT FROM SALES REP REGARDING ONE INCIDENT INVOLVING AN ACCESS NEEDLE FOR THE STEP DISPOSABLE PRODUCT. DEFINITIVE AND CONFIRMING INFO WAS REPORTED ON MONDAY, AUGUST 30, 1999 REGARDING THIS INCIDENT. THE EPISODE OCCURRED AT A SURGICAL CENTER, DURING A LAPAROSCOPIC PROCEDURE UNDER THE HAND OF THE DOCTOR. ON AUGUST 27, 1999, A LASER LAPAROSCOPIC GYNECOLOGIC PROCEDURE WAS UNDERTAKEN BY THE PHYSICIAN. THE VERESS NEEDLE WAS PLACED INSIDE THE RADIALLY EXPANDING SLEEVE AND INTRODUCED INTO THE ABDOMINAL CAVITY VIA A "BIND STICK" APPROACH. [THIS IS NOT PROPER PLACEMENT OF THE STEP DEVICE WAS OUTLINED IN THE INSTRUCTIONS FOR USE FOR THIS PRODUCT (P/N 01091C) AS NO NEEDLE PLACEMENT TEST WAS PERFORMED AND NO PRE DILATION INSUFFLATION OCCURRED.] UPON ATTEMPTING TO INSUFFLATE THE CAVITY, COMPLICATIONS WERE ENCOUNTERED. THE RADIALLY EXPANDABLE SLEEVE WAS DILATED WITH A 10MM CANNULA/DILATOR ASSEMBLY FOLLOWED BY A VISUAL SCOPE PLACED THROUGH THE WORKING CHANNEL. UPON VISUALIZATION IT WAS OBSERVED THAT INADVERTENT PERFORATION AND DILATION THROUGH THE BOWEL HAD OCCURRED. CONVERSION TO AN OPEN PROCEDURE WAS UNDERTAKEN FOR REPAIR AND CONTINUATION OF THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER REPORT OF INCIDENT. THE SURGICAL CENTER WAS CONTACTED FOR STATUS/CONDITION OF THE PT, WITH THE PT BEING REPORTED IN 'SATISFACTORY' CONDITION AND RECOVERING. (NOTE: THE PT HAD BEEN REMOVED TO ANOTHER HOSPITAL AFTER THE SURGERY ON 08/27/99). THEREFORE, THE EVENT IS REPORTED AS IN INADVERTANT PT INJURY REQUIRING SURGICAL CORRECTION. THE INVOLVED PRODUCT WAS NOT RETURNED TO INNERDYNE, INC. AT THE TIME OF THIS REPORT SO N INVESTIGATION OF THE PRODUCT HAS NOT BEEN CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSUFFLATION & ACCESS NEEDLE ACCESS NEEDLE GCJ INNERDYNE, INC. S100000 IG17927

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention