BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIX® UNIVERSAL CLIP APPLIER

    MDR report key: 22682058 · Received July 31, 2025

    Report

    Report Number
    2027111-2025-00675
    Event Type
    Malfunction
    Date Received
    July 31, 2025
    Date of Event
    July 2, 2025
    Report Date
    November 26, 2025
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    FZP
    PMA / PMN Number
    K011236
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: G2, CORRECTING REPORT SOURCE. THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. FUNCTIONAL TESTING WAS PERFORMED ON THE EVENT UNIT, WHICH CONFIRMED THE COMPLAINANT¿S EXPERIENCE OF THE CLIP NOT LOADING INTO THE JAWS. APPLIED MEDICAL HAS REVIEWED THE DETAILS SURROUNDING THE EVENT AND RELATED PRODUCTS AND IS UNABLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT BASED ON THE EVALUATION OF THE RETURNED UNIT. APPLIED MEDICAL HAS PERFORMED A HISTORICAL TREND ANALYSIS AND REVIEW OF PRODUCTION RECORDS AND NO RELEVANT DOCUMENTATIONS WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    THE EVENT DEVICE IS ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    NAME OF PROCEDURE: COELIO VESICLE. EVENT DESCRIPTION: THE CLIP APPLIERS REFERENCE CA500 EXPIRATION DATE 12/2027 IS DYSFUNCTIONAL. THERE WAS NO DAMAGE OR IMPACT ON THE PATIENT. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 09JULY25: PATIENT IS OK. NO CLIP HAS BEEN INSERTED INTO THE JAWS BEFORE THE INSTRUMENT IS INSERTED OR REMOVED BY THE TROCAR. THE TRIGGER COULD BE PULLED EASILY AND COMPLETELY. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 23JUL25: THE TROCAR MODEL USED WAS CFB12. AT THE TIME OF ACTION IT WAS IMPOSSIBLE TO RELEASE A CLIP, THE DEVICE WAS BLOCKED, THERE WAS NO CLIP BETWEEN THE JAWS, THE CA500 WAS STUCK. PATIENT STATUS: THERE WAS NO DAMAGE OR IMPACT ON THE PATIENT. PATIENT IS OK. INTERVENTION: OPENING ANOTHER CLIP.

    Description of Event or Problem · 0

    NAME OF PROCEDURE: COELIO VESICLE. EVENT DESCRIPTION: THE CLIP APPLIERS REFERENCE CA500 EXPIRATION DATE 12/2027 IS DYSFUNCTIONAL. THERE WAS NO DAMAGE OR IMPACT ON THE PATIENT. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 09JULY25: PATIENT IS OK. NO CLIP HAS BEEN INSERTED INTO THE JAWS BEFORE THE INSTRUMENT IS INSERTED OR REMOVED BY THE TROCAR. THE TRIGGER COULD BE PULLED EASILY AND COMPLETELY. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 23JUL25: THE TROCAR MODEL USED WAS CFB12. AT THE TIME OF ACTION IT WAS IMPOSSIBLE TO RELEASE A CLIP, THE DEVICE WAS BLOCKED, THERE WAS NO CLIP BETWEEN THE JAWS, THE CA500 WAS STUCK. PATIENT STATUS: THERE WAS NO DAMAGE OR IMPACT ON THE PATIENT. PATIENT IS OK. INTERVENTION: OPENING ANOTHER CLIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198521 EPIX® UNIVERSAL CLIP APPLIER CLIP, IMPLANTABLE FZP APPLIED MEDICAL RESOURCES CA500 1542697

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown TROCAR CFB12