BEUDAMED
    FDA Adverse Event Summary report: N

    EPIX UNIVERSAL CLIP APPLIER

    MDR report key: 2885272 · Received December 18, 2012

    Report

    Report Number
    2027111-2012-00398
    Date Received
    December 18, 2012
    Date of Event
    November 30, 2012
    Report Date
    December 18, 2012
    Manufacturer
    APPLIED MEDICAL
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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

    LAPAROSCOPIC CHOLECYSTECTOMY - "DEVICE APPEARED TO FAIL TO LOAD CLIP IN JAWS OF THE CLIP APPLIER. SHORTLY AFTERWARDS, THE JAWS OF THE CLIP APPLIER DETACHED FROM THE SHAFT OF THE CLIP APPLIER. SURGEON REMOVED THE 5MM EPIGASTRIC PORT AND PLACED A 1MM PORT. SURGEON RETRIEVED THE DETACHED JAWS FROM THE ABDOMEN OF THE PATIENT. SURGEON THEN INSERTED A SECOND CA500 INTO THE ABDOMEN, AND VERY QUICKLY COMMENTED THAT THIS CLIP APPLIER WAS JAMMED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIX UNIVERSAL CLIP APPLIER NONE FZP APPLIED MEDICAL CA500 1169509

    Patients

    Seq Age Sex Outcome Treatment
    1 10 MM CLIP APPLIER| 11 MM PORT