BEUDAMED
    FDA Adverse Event Summary report: N

    DIRECT DRIVE CLIP APPLIER 10MM 3/BOX

    MDR report key: 2861741 · Received December 4, 2012

    Report

    Report Number
    2027111-2012-00373
    Date Received
    December 4, 2012
    Date of Event
    November 7, 2012
    Report Date
    December 4, 2012
    Manufacturer
    APPLIED MEDICAL
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE IS ANTICIPATED TO BE RETURNED. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION. IN ACCORDANCE WITH 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

    GALL BLADDER REMOVAL - "THE JAW OF THE CLIP APPLIER DID NOT CLOSE, THEREBY UNABLE TO PERFORM PROPER LIGATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIRECT DRIVE CLIP APPLIER 10MM 3/BOX NONE FZP APPLIED MEDICAL CA090 1156064

    Patients

    Seq Age Sex Outcome Treatment
    1