BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEP S/C/D 10MM

    MDR report key: 237141 · Received August 26, 1999

    Report

    Report Number
    1721520-1999-00007
    Event Type
    Injury
    Date Received
    August 26, 1999
    Date of Event
    August 24, 1999
    Report Date
    August 26, 1999
    Manufacturer
    INNERDYNE, INC.
    Product Code
    GCJ
    Removal / Correction Number
    901182
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON TUESDAY, 24 AUGUST 1999, PRELIMINARY INFORMATION WAS RECEIVED BY INNERDYNE, INC., QUALITY COMPLIANCE DEPARTMENT FROM SALES REP, REGARDING ONE (1) INCIDENT INVOLVING AN ACCESS NEEDLE FROM THE STEP DISPOSABLE PRODUCT. DEFINITIVE AND CONFIRMING INFORMATION WAS REPORTED ON WEDNESDAY, 25 AUGUST 1999 REGARDING THIS INCIDENT. THE EPISODE OCCURRED AT A HOSP DURING A LASER LAPAROSCOPIC PROCEDURE UNDER THE HAND OF A DR. ON 8/24/99 A LASER LAPAROSCOPIC GYNECOLOGIC PROCEDURE WAS UNDERTAKEN BY THE PHYSICIAN. THE PATIENT HAD UNDERGONE PRIOR ABDOMINAL SURGERY. THE BARE ACCESS NEEDLE WAS PROPERLY PLACED, FOLLOWED BY SUCCESSFUL INSUFFLATION. THE NEEDLE WAS REMOVED AND PLACED THROUGH THE EXPANDABLE SLEEVE, WHICH WAS THEN REINSERTED INTO THE CREATED TRACT ACCORDING TO ESTABLISHED INSTRUCTIONS. THE RADIALLY EXPANDING SLEEVE WAS DILATED WITH A 10MM CANNULA/DILATOR ASSEMBLY FOLLOWED BY A VISUAL SCOPE PLACED THROUGH THE WORKING CHANNEL. UPON VISUALIZATION, SOMETHING WAS NOT RIGHT AND THE PATIENT WAS TAKEN TO X-RAY WHERE IT WAS CONFIRMED THAT THE BOWEL HAD BEEN INADVERTENTLY PERFORATED AND DILATED. 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 HOSPITAL WAS CONTACTED FOR STATUS/CONDITION OF PATIENT, BUT RISK MANAGEMENT REFUSED TO COMMENT ON THE MATTER. THEREFORE, THE EVENT IS REPORTED AS AN INADVERTENT PATIENT INJURY REQUIRING SURGICAL CORRECTION. THE INVOLVED PRODUCT WAS NOT RETURNED TO INNERDYNE, INC., SO AN INVESTIGATION OF THE PRODUCT WAS NOT CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEP S/C/D 10MM STEP ACCESS NEEDLE GCJ INNERDYNE, INC. S100000 UNREPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention