BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTO SUTURE ENDO CLIP 5MM

    MDR report key: 251494 · Received November 23, 1999

    Report

    Report Number
    1219161-1999-01019
    Event Type
    Injury
    Date Received
    November 23, 1999
    Date of Event
    October 22, 1999
    Report Date
    October 25, 1999
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. REPORTEDLY, THE INSTRUMENT JAMMED AND WAS DIFFICULT TO OPEN. THE DUCT HAD TO BE CUT IN ORDER TO REMOVE THE DEVICE. THE PT RETURNED ON OCTOBER 25, 1999 AND UNDERWENT AN ENDOSCOPIC RETROGRADE CHOLANGIO PANCREATOGRAPHY. NO PIECES WERE FOUND. THE HOSP HAS REPORTED THE PT'S CONDITION AS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE ENDO CLIP 5MM DISPOSABLE CLIP APPLIER GCJ UNITED STATES SURGICAL CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention