BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTO SUTURE SURGINEEDLE 150MM

    MDR report key: 208685 · Received February 3, 1999

    Report

    Report Number
    1219161-1999-00095
    Event Type
    Injury
    Date Received
    February 3, 1999
    Date of Event
    July 31, 1992
    Report Date
    October 7, 1998
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A LAPAROSCOPIC TUBAL LIGATION PROCEDURE TO ESTABLISH PNEUMOPERITONEUM. REPORTEDLY, ON AUGUST 26, 1992 THE PT RETURNED FOR A POST-OPERATIVE VISIT AND COMPLAINED OF LOWER ABDOMINAL/PELVIC PAIN. ON JUNE 14, 1993 THE PT DEVELOPED AN ABSCESS IN THE GLUTEAL AREA. ON MARCH 15, 1994 THE PT WAS ADMITTED TO HOSP WITH A PERI-RECTAL GRANULOMA AND ABSCESS TO BE DRAINED. THE GRANULOMA WAS EXCISED AND A FOREIGN BODY WAS REMOVED FROM THE PT. THE FOREIGN BODY APPEARED A VERESS NEEDLE. ON SEPTEMBER 25, 1996 THE PT HAD AN EXPLORATORY LAPAROSCOPIC PROCEDURE TO IDENTIFY THE SOURCE OF HER CHRONIC PELVIC PAIN. ADHESIONS WERE NOTED AND TREATED AS WELL AS THE REMOVAL OF THE REMAINING FALLOPIAN TUBES. NO OTHER FOREIGN BODIES WERE NOTED. THE HOSP HAS REPORTED THE PT'S CONDITION IS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE SURGINEEDLE 150MM DISPOSABLE PNEUMOPERITONEUM NEEDLE GCJ UNITED STATES SURGICAL CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention