BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIX UNIVERSAL CLIP APPLIER

    MDR report key: 2782033 · Received September 12, 2012

    Report

    Report Number
    2782033
    Event Type
    Malfunction
    Date Received
    September 12, 2012
    Date of Event
    July 11, 2012
    Report Date
    September 11, 2012
    Manufacturer
    APPLIED MEDICAL
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    (B)(6) 2012 - LAPAROSCOPIC CHOLECYSTECTOMY PERFORMED, DISCHARGED HOME ON (B)(6) 2012. RECEIVED A PHONE CALL FROM PATIENT ON (B)(6) 2012, WITH CONTINUED ABDOMINAL SWELLING ON RIGHT SIDE, SWINGING SENSATION IN ABDOMEN, ABDOMINAL PAIN WITH BENDING AND PRESSURE IN HER ABDOMEN. PATIENT STATED THAT SHE HAD BEEN TO HER PCP APPROXIMATELY 3 WEEKS AGO WITH THE SYMPTOMS AND THE SYMPTOMS HAVE CONTINUED. SHE WAS INSTRUCTED BY (B)(6) SURGICAL PRACTICE TO GO TO HER PCP OR GO TO AN EMERGENCY ROOM. ON (B)(6) 2012, RECEIVED A FAX FROM PATIENTS PCP OF CT REPORT INDICATING A BILE LEAK. HAVE TRIED CONTACTING PATIENT WITH NO SUCCESS. DO NOT KNOW IF SURGICAL INTERVENTION WAS NEEDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other