BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM ONE-STEP

    MDR report key: 211408 · Received February 24, 1999

    Report

    Report Number
    1721520-1999-00002
    Event Type
    Injury
    Date Received
    February 24, 1999
    Date of Event
    February 3, 1999
    Report Date
    February 24, 1999
    Manufacturer
    INNERDYNE, INC.
    Product Code
    GCJ
    Removal / Correction Number
    900948
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON THURSDAY, 18 1999, PRELIMINARY INFO WAS RECEIVED BY THE INNERDYNE, INC., QUALITY COMPLIANCE DEPT FROM SALES REP, CHELMSFORD MA, REGARDING ONE (1) INCIDENT INVOLVING AN ACCESS NEEDLE FROM THE PREMIUM ONE STEP DISPOSABLE PRODUCT. DEFINITIVE AND CONFIRMING INFO WAS REPORTED ON WEDNESDAY 2/24/99 REGARDING THIS INCIDENT. THE EPISODE OCCURRED DURING A LAPAROSCOPIC PROCEDURE UNDER THE HAND OF DR. ON 2/3/99, THE PROCEDURE WAS UNDERTAKEN, UNDER A STERILE DEMO BASIS, THIS BEING THE FIRST USE OF THE PRODUCT BY THE PHYSICIAN. THE PT HAD UNDERGONE PRIOR ABDOMINAL SURGERY, AND ADHESIONS WERE KNOWN TO BE PRESENT. UPON ENTRY WITH THE ACCESS NEEDLE EXCESSIVE FORCE WAS NEEDED TO PENETRATE THE ABDOMEN DUE TO THE PRESENTATION OF ADHESIONS. AFTER PENETRATION OF THE CAVITY, A SMALL BOWEL PERFORATION WAS NOTICED WHICH WAS REPAIRED USING ONE (1) SUTURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER INCIDENT. THE PT IS REPORTED FINE AT THIS TIME, RECUPERATING WITHOUT MEDICAL SEQUELAE. THEREFORE, THE EVENT IS REPORTED AS A PT 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 PREMIUM ONE-STEP ACCESS NEEDLE GCJ INNERDYNE, INC. S100000 HK16853

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other