BEUDAMED
    FDA Adverse Event Summary report: N

    DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3.BOX

    MDR report key: 2885270 · Received December 18, 2012

    Report

    Report Number
    2027111-2012-00396
    Date Received
    December 18, 2012
    Date of Event
    November 20, 2012
    Report Date
    December 18, 2012
    Manufacturer
    APPLIED MEDICAL
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    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 ADDITIONAL INFORMATION 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 - "WHEN THE CLIP WAS APPLIED, THE TOP PART OF THE CLIP DIDN'T CLOSE ALL THE WAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3.BOX NONE FZP APPLIED MEDICAL CA090 1167925

    Patients

    Seq Age Sex Outcome Treatment
    1