BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3/BOX

    MDR report key: 1982752 · Received November 8, 2010

    Report

    Report Number
    2027111-2010-00102
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    September 6, 2010
    Report Date
    November 8, 2010
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INCIDENT WAS REPORTED TO THE FDA ON UF/IMPORTER REPORT # (B)(4). THE PRODUCT IS CURRENTLY BEING RETURNED FOR EVAL, A F/U REPORT WILL BE SENT WITHIN 30 DAYS OR UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    INCIDENT AS REPORTED ON MEDWATCH REPORT (UF/IMPORTER REPORT # (B)(4)): LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE -"THE SURGEON USED A LAPAROSCOPIC CLIP APPLIER FROM APPLIED MEDICAL AND THE TIP OF THE APPLIER BROKE OFF IN THE PT'S ABDOMEN. INCIDENT AS REPORTED ON CUSTOMER EXPERIENCE REPORT: LAPAROSCOPIC CHOLE -"WHEN CLIPPING THE CYSTIC DUCT AND THEN ADVANCING CLIP TO CLAMP DOWN TO SEAL THE CYSTIC DUCT, THE CLIP TIP BROKE OFF INTO THE PT. THE METAL PIECE WAS RETRIEVED AND DID NOT STAY INSIDE THE PT. DAMAGED PIECE WAS RETRIEVED CAUSING NO HARM TO PT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3/BOX NONE GDO APPLIED MEDICAL RESOURCES CA090 1118776

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR