BEUDAMED
    FDA Adverse Event Summary report: N

    EPIX UNIVERSAL CLIP APPLIER

    MDR report key: 2861745 · Received November 26, 2012

    Report

    Report Number
    2027111-2012-00370
    Date Received
    November 26, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 26, 2012
    Manufacturer
    APPLIED MEDICAL
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    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

    LAP CHOLE - " SURGEON PUT THE CLIP ON THE DUCT AND IT WAS "SLIDING" BACK AND FORTH, ALMOST LIKE IT WASN'T FULLY CLOSED. I WATCHED HIM USE IT AND HE PULLED THE TRIGGER ALL THE WAY BACK, PLASTIC TO PLASTIC. HE HAD ALREADY PLACED TWO CLIPS PRIOR AND THERE WAS NO ISSUE. HE CONTINUED TO USE IT THROUGHOUT THE CASE AND IT WORKED FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIX UNIVERSAL CLIP APPLIER NONE FZP APPLIED MEDICAL CA500 1175530

    Patients

    Seq Age Sex Outcome Treatment
    1 LAPAROSCOPIC INSTRUMENTS GRASPERS| LAPAROSCOPIC INSTRUMENTS SCOPES