BEUDAMED
    FDA Adverse Event Other Summary report: N

    DISPOSABLE CLIP APPLIER DIRECT DRIVE 10MM

    MDR report key: 860737 · Received June 4, 2007

    Report

    Report Number
    2027111-2007-00043
    Event Type
    Other
    Date Received
    June 4, 2007
    Date of Event
    May 4, 2007
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT BEEN RETURNED TO THE MFR FOR EVAL. IF PRODUCT IS RETURNED EVAL WILL BE COMPLETED AND FINAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    "SURGEON PLACED 1 CLIP ON CYSTIC DUCT, SPECIMEN SIDE AND 2 CLIPS ON PT SIDE OF DUCT. ONCE HE TRANSECTED THE DUCT, THE CLIP ON THE SPECIMEN SIDE WAS ONLY PARTIALLY FORMED. HE THEN PLACED 2 CLIPS ON CYSTIC ARTERY ON PT SIDE, 1 CLIP ON SPECIMEN SIDE. TRANSECTED, SEVERE BLEEDING AND ONE CLIP MISSING ON PT SIDE. HE THEN PLACED A THIRD CLIP ON THE CYSTIC ARTERY, BECAUSE ONE HAD COME OFF." PT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE CLIP APPLIER DIRECT DRIVE 10MM NONE GDO APPLIED MEDICAL RESOURCES CORP. CA080 1028395

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other