BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEP NEEDLE

    MDR report key: 115554 · Received August 27, 1997

    Report

    Report Number
    1721520-1997-00004
    Event Type
    Malfunction
    Date Received
    August 27, 1997
    Date of Event
    August 11, 1997
    Report Date
    August 26, 1997
    Manufacturer
    INNERDYNE, INC.
    Product Code
    GCJ
    Removal / Correction Number
    900405
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE ON A 56 YR OLD FEMALE PT, UNDERGOING A LAPAROSCOPIC VAGINAL HYSTERECTOMY, UNDER THE DIRECTION OF A DR., ON 11 AUGUST 1997. DURING THE PROCEDURE, A STANDARD STEP RADIALLY EXPANDING DILATION ACCESS DEVICE AND SLEEVE WAS USED ACCORDING TO INSTRUCTIONS. UPON ABDOMINAL RE-EXPLORATION DURING THE PROCEDURE A FOREIGN BODY WAS OBSERVED AND RETRIEVED. THE RETRIEVED MATERIAL WAS THE BLUNT STYLETTE OF THE INSUFFLATION NEEDLE, WHICH HAD BECOME DETACHED FROM THE ASSEMBLED NEEDLE UNIT. SUCCESSFUL RETRIEVAL OF THE STYLETTE WAS ACCOMPLISHED BY THE ATTENDING SURGEON, AND NO PT INJURY IS REPORTED. THE PT IS REPORTED TO HAVE RECOVERED FROM THE SCHEDULED PROCEDURE AND IS DOING FINE WITHOUT COMPLICATION. THE REPORTED EVENT IS DESCRIBED AS A PRODUCT MALFUNCTION/FAILURE. THE MALFUNCTIONED NEEDLE ASSEMBLY IS BEING RETURNED TO INNERDYNE, INC., FOR EVALUATION, WHICH HAS YET TO BE RECEIVED AND COMPLETED. THE RETRIEVED STYLETTE WAS RETAINED BY THE MEDICAL INSTITUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEP NEEDLE INSUFFLATION & ACCESS NEEDLE GCJ INNERDYNE, INC. NA GF14333

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention