BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX

    MDR report key: 19130899 · Received April 18, 2024

    Report

    Report Number
    2027111-2024-00583
    Event Type
    Malfunction
    Date Received
    April 18, 2024
    Date of Event
    February 16, 2024
    Report Date
    June 26, 2024
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    FZP
    UDI-DI
    00607915125318
    PMA / PMN Number
    K011236
    Removal / Correction Number
    2027111-01/26/24-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APPLIED MEDICAL HAS ISSUED A VOLUNTARY RECALL OF OUR EPIX UNIVERSAL CLIP APPLIER FOR SPECIFIC CA500 LOTS. THESE CA500 UNITS ARE BEING RECALLED DUE TO A NONCONFORMANCE THAT MAY RESULT IN A CLIP NOT LOADING INTO THE JAWS AFTER THE TRIGGER IS ACTUATED. APPLIED MEDICAL HAS RECENTLY IMPLEMENTED MANUFACTURING CORRECTIONS WHICH ARE INTENDED TO REDUCE THE POTENTIAL FOR THIS TYPE OF INCIDENT TO REOCCUR. THE LOT ASSOCIATED WITH THIS COMPLAINT, #(B)(4). , WAS INCLUDED IN THE RECALL.

    Additional Manufacturer Narrative · 0

    APPLIED MEDICAL HAS ISSUED A VOLUNTARY RECALL OF OUR EPIX UNIVERSAL CLIP APPLIER FOR SPECIFIC CA500 LOTS. THESE CA500 UNITS ARE BEING RECALLED DUE TO A NONCONFORMANCE THAT MAY RESULT IN A CLIP NOT LOADING INTO THE JAWS AFTER THE TRIGGER IS ACTUATED. APPLIED MEDICAL HAS RECENTLY IMPLEMENTED MANUFACTURING CORRECTIONS WHICH ARE INTENDED TO REDUCE THE POTENTIAL FOR THIS TYPE OF INCIDENT TO REOCCUR. THE LOT ASSOCIATED WITH THIS COMPLAINT(B)(4) WAS INCLUDED IN THE RECALL.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: LAP-CHOLE EVENT DESCRIPTION: (B)(4). CUSTOMER WANTED TO CLIP THE CYSTIC-DUCT. WHEN PRELOADING, COMES NO CLIP OUT OF THE APPLIER. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REP VIA EMAIL ON 12APR24: THE "NOT PROPERLY WORKING¿ CLIP APPLIER HAVE BEEN COLLECTED OVER SEVERAL WEEKS, SO IT IS NOT EASY TO RECEIVE DETAILED INFORMATION. WHAT OFTEN HAPPENED WAS THAT FROM THE BEGINNING NO CLIP WAS CHARGED BETWEEN THE JAWS BY ACTIVATING THE TRIGGER. PATIENT STATUS: NO INJURY INTERVENTION: OPENED A NEW ONE.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: LAP-CHOLE. EVENT DESCRIPTION: COMPLAINT 1 OF 9: 2024-000508, COMPLAINT 2 OF 9: 2024-000932, COMPLAINT 3 OF 9: 2024-000933, COMPLAINT 4 OF 9: 2024-000934,, COMPLAINT 5 OF 9: 2024-000935, COMPLAINT 6 OF 9: 2024-000936, COMPLAINT 7 OF 9: 2024-000937, COMPLAINT 8 OF 9: 2024-000938, COMPLAINT 9 OF 9: 2024-000944. CUSTOMER WANTED TO CLIP THE CYSTIC-DUCT. WHEN PRELOADING, COMES NO CLIP OUT OF THE APPLIER. PATIENT STATUS: NO INJURY. INTERVENTION: OPENED A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2238346 CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX CLIP, IMPLANTABLE FZP APPLIED MEDICAL RESOURCES CA500 1491916 00607915125318

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown TROKARS