BEUDAMED
    FDA Adverse Event Summary report: N

    EPIX UNIVERSAL CLIP APPLIER

    MDR report key: 2941664 · Received January 18, 2013

    Report

    Report Number
    2027111-2013-00009
    Date Received
    January 18, 2013
    Date of Event
    November 12, 2012
    Report Date
    January 18, 2013
    Manufacturer
    APPLIED MEDICAL
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    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 - "PT WAS PRESENTED TO THE HOSPITAL'S OPERATING ROOM FOR LAPAROSCOPIC CHOLECYSTECTOMY RELATED TO HER DIAGNOSIS OF ACUTE CHOLECYSTITIS. THE PT WHILE IN THE OPERATING ROOM HAD AN EPIC UNIVERSAL CLIP APPLIER USED. THE CLIP APPLIER WAS REPORTED BY THE SURGEON TO MISFIRE MULTIPLE TIMES DURING THE PROCEDURE. THE EVENT WAS DESCRIBED WAS "WHEN WE WOULD CLAMP. IT WOULD NOT STAPLE, WHEN WE WOULD UNCLAMP, THE STAPLE WOULD FALL OUT." PATIENT STATUS: PATIENT DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28414 EPIX UNIVERSAL CLIP APPLIER NONE FZP APPLIED MEDICAL CA500 1167850

    Patients

    Seq Age Sex Outcome Treatment
    1