BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIRECT DRIVE DISPOSABLE CLIP APPLIER 10 MM 3/ BOX

    MDR report key: 3113227 · Received May 8, 2013

    Report

    Report Number
    2027111-2013-00168
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Report Date
    May 6, 2013
    Manufacturer
    APPLIED MEDICAL
    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 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

    LAPAROSCOPIC CHOLECYSTECTOMY - "THE CLIPS DID NOT FULLY CLOSE AFTER FIRING." PATIENT STATUS: OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200138 DIRECT DRIVE DISPOSABLE CLIP APPLIER 10 MM 3/ BOX NONE FZP APPLIED MEDICAL CA090 1176617

    Patients

    Seq Age Sex Outcome Treatment
    1