BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEP S/C/D

    MDR report key: 225553 · Received June 2, 1999

    Report

    Report Number
    1721520-1999-00004
    Event Type
    Injury
    Date Received
    June 2, 1999
    Date of Event
    May 28, 1999
    Report Date
    June 1, 1999
    Manufacturer
    INNERDYNE, INC.
    Product Code
    GCJ
    Removal / Correction Number
    901043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE EPISODE OCCURRED DURING A LAPAROSCOPIC PROCEDURE. ON 5/28/99 A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY (LAVH) PROCEDURE WAS UNDERTAKEN. THE PT HAD UNDERGONE PRIOR ABDOMINAL MIDLINE SURGERY, C-SECTION. THE BARE ACCESS NEEDLE WAS PLACED AT THE UMBILICUS SITE, WITH ACCEPTABLE DROP/ASPIRATION TESTING. THE ABDOMEN WAS INSUFFLATED, WITH A NOTED HIGH PRESSURE. UPON REMOVAL OF THE NEEDLE, BOWEL CONTENTS CONTAMINATION WAS NOTED. GENERAL SURGERY WAS CONTACTED AND CONVERSION TO AN OPEN PROCEDURE WAS INITIATED FOR CORRECTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER INCIDENT. THE PT IS REPORTED FINE AT THIS TIME, RECUPERATING WITHOUT MEDICAL SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEP S/C/D STEP ACCESS NEEDLE GCJ INNERDYNE, INC. S100000 HL16990

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention