BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEP

    MDR report key: 205534 · Received January 12, 1998

    Report

    Report Number
    1721520-1999-00001
    Event Type
    Injury
    Date Received
    January 12, 1998
    Manufacturer
    INNERDYNE, INC.
    Product Code
    GCJ
    Removal / Correction Number
    900902
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON WEDNESDAY, 12/30/98, PRELIMINARY INFO WAS REC'D BY THE INNERDYNE INC, QUALITY COMPLIANCE DEPT FROM MARKETING MANAGER REGARDING ONE (1) INCIDENT INVOLVING A 5MM STEP DISPOSABLE PRODUCT. DEFINITIVE AND CONFIRMING F/U INFO WAS REPORTED ON MONDAY 1/4/99 REGARDING THIS INCIDENT. THE EPISODE OCCURRED AT HOSPITAL DURING A NISSEN FUNDOPLICATION PROCEDURE ON A 10 MONTH OLD MALE PT UNDER THE HAND OF DR. ON 12/15/98 THE PROCEDURE WAS UNDERTAKEN USING AN ETHICON TROCAR FOR THE UMBILICAL PORT AND TWO (2) 5MM STEP PRODUCTS FOR THE UPPER LATERAL QUADRANT AND LOWER LATERAL QUADRANT RESPECTIVELY. CONVERSION TO AN OPEN SURGERY FOR REASONS UNRELATED TO ANY OF THE ACCESS PORTS AND THE PROCEDURE WAS CONCLUDED. APPROX ONE (1) WEEK POST-OP, THE PT RETURNED WITH A CLINICALLY REDUCIBLE INCISIONAL HERNIA IN THE LOWER LATERAL QUADRANT PORT SITE. UPON EXAMINATION IT WAS FELT THAT THE PRESENTED HERNIATION WOULD RESOLVE ITSELF WITHIN A FEW DAYS/WEEKS, WITHOUT SURGICAL REPAIR. ON 12/28/98 THE PT AGAIN RETURNED AND A DIAGNOSTIC LAPAROTOMY WAS PERFORMED. UPON COMMENCING THE PROCEDURE IT WAS BELIEVED THAT ADHESIONS FROM THE ORIGINAL SURGERY WOULD BE THE ISSUE, BUT UPON THE ABDOMEN, A 1-2CM PERFORATED STRANGULATED SECTION OF THE ILEUM WAS OBSERVED TO BE INCARCERATED IN THE LOWER LEFT QUADRANT PORT SITE. THE IDENTIFIED/LOCATED HERNIATION WAS SUCCESSFULLY REPAIRED VIA STANDARD SURGICAL TECHNIQUE WITHOUT COMPLICATION, AND THE PROCEDURE CONCLUDED. THE PT IS REPORTED STABLE AND FINE AT THIS TIME, SUCCESSFULLY RECUPERATING WITHOUT ADD'L SEQUELAE. THEREFORE, THE EVENT IS REPORTED AS A PT INJURY REQUIRING ADD'L SURGICAL INTERVENTION FOR CORRECTION. THE INVOLVED PRODUCT WAS NEITHER AVAILABLE NOR RETURNED TO INNERDYNE, INC, SO AN INVESTIGATION OF THE INVOLVED PRODUCT WAS NOT CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEP 5MM S/C/D GCJ INNERDYNE, INC. S101005 UNREPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 10 MO Required Intervention