BEUDAMED
    FDA Adverse Event Summary report: N

    DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3/BOX

    MDR report key: 2842487 · Received November 13, 2012

    Report

    Report Number
    2027111-2012-00348
    Date Received
    November 13, 2012
    Date of Event
    October 29, 2012
    Report Date
    November 13, 2012
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE ANTICIPATED TO RETURN. A FOLLOW UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION. IN ACCORDANCE TO 21 CFR 803.56. IF WE OBTAIN ADD¿L INFO, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    LAP CHOLE ¿DOCTOR SAID THE CLIP DIDN¿T CLOSE FULLY. ALMOST LIKE IN CHOLANGIOGRAM ZONE. OPENED ANOTHER CLIP THAT WORKED.¿ PATIENT STATUS: ¿¿DISCHARGED , NO PROBLEMS¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3/BOX NONE FZP APPLIED MEDICAL RESOURCES CORP. CA090 1171481

    Patients

    Seq Age Sex Outcome Treatment
    1