BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIX® UNIVERSAL CLIP APPLIER

    MDR report key: 23381128 · Received October 24, 2025

    Report

    Report Number
    2027111-2025-00824
    Event Type
    Malfunction
    Date Received
    October 24, 2025
    Date of Event
    August 19, 2025
    Report Date
    February 17, 2026
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    FZP
    UDI-DI
    00607915125318
    PMA / PMN Number
    K011236
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. AS THE EVENT UNIT WAS NOT RETURNED, APPLIED MEDICAL IS UNABLE TO DETERMINE IF THE EVENT UNIT EXHIBITED ANY NON-CONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. IN THE ABSENCE OF THE EVENT UNIT, IT IS DIFFICULT TO DETERMINE IF THE REPORTED EVENT WAS CAUSED BY A MANUFACTURING NON-CONFORMANCE OR CIRCUMSTANTIAL FACTORS AT THE TIME OF USE. APPLIED MEDICAL HAS REVIEWED THE DETAILS SURROUNDING THE EVENT AND IS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE EVENT. APPLIED MEDICAL HAS PERFORMED A HISTORICAL TREND ANALYSIS AND REVIEW OF PRODUCTION RECORDS AND NO TRENDS WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    NAME OF PROCEDURE: NA. EVENT DESCRIPTION: APPLIED MEDICAL CA500 5: SHAFT TOO THICK, CLIPS CROSS AND TIPS DON'T MEET, NOT SMOOTH APPLICATION (HANDLE CRUNCHY). CLIPS TOO BIG. QUALITY DOES NOT MEET STANDARD OF SIMILAR PRODUCT ALREADY ON SHELF. [REFERENCE NUMBER] QUALITY REPORT: SHAFT TOO THICK. CLIPS CROSS AND TIPS DON'T MEET. CLIPS TOO BIG. AUSTRALIAN MEDICAL DEVICE INCIDENT REPORT (DIR 121913): SHAFT TOO THICK. CLIPS CROSS AND TIPS DON'T MEET. CLIPS TOO BIG. SUMMARY FOR COMPLAINTS REVIEW BOARD INTEL RECEIVED ON 14 OCTOBER 2025 - CLINICAL DEVELOPMENT SPOKE TO [NAME] ON PHONE [NAME] ADVISED THAT SEVERAL WEEKS AGO, THE NURSES OPENED UP A LAP APPY TRAY (INCLUDING AM 5 MM PORT AND CA500) AND DID A MOCK DEMO ¿ IE. INSERTED CA500 INTO AM 5 MM TROCAR AND IT WAS ¿TOO FORCEFUL¿ ¿ SHE COULD NOT CONFIRM IF Z-THREAD OR ADV FIX. [NAME] STATED NURSES ([NAME], [NAME] AND [NAME] WERE ALL IN ATTENDANCE ¿ NO DRS) FOUND IT ¿DANGEROUS¿ AS SHAFT WAS TOO SNUG AND HAD TO BE ¿JAMMED¿ DOWN TROCAR FOR IT TO FIT ¿ STATING IT WOULD HARM BOWEL ETC. IT ¿COULD NOT BE DONE ONE HANDED¿ COMPLAINT WAS THEN LODGED = AND QUALITY REPORTS WERE SUBMITTED. NO REASON WAS GIVEN AS TO WHY THEY DID THE PRODUCT DEMO. INTERVENTION: NA. PATIENT STATUS: NA.

    Description of Event or Problem · 0

    NAME OF PROCEDURE: . EVENT DESCRIPTION: APPLIED MEDICAL CA500 5: SHAFT TOO THICK, CLIPS CROSS AND TIPS DON'T MEET, NOT SMOOTH APPLICATION (HANDLE CRUNCHY). CLIPS TOO BIG. QUALITY DOES NOT MEET STANDARD OF SIMILAR PRODUCT ALREADY ON SHELF. [REFERENCE NUMBER] QUALITY REPORT: SHAFT TOO THICK. CLIPS CROSS AND TIPS DON'T MEET. CLIPS TOO BIG. AUSTRALIAN MEDICAL DEVICE INCIDENT REPORT (DIR (B)(4): SHAFT TOO THICKC. LIPS CROSS AND TIPS DON'T MEET. CLIPS TOO BIG. SUMMARY FOR COMPLAINTS REVIEW BOARD INTEL RECEIVED ON 14 OCTOBER 2025 - CLINICAL DEVELOPMENT SPOKE TO [NAME] ON PHONE [NAME] ADVISED THAT SEVERAL WEEKS AGO, THE NURSES OPENED UP A LAP APPY TRAY (INCLUDING AM 5 MM PORT AND CA500) AND DID A MOCK DEMO ¿ IE. INSERTED CA500 INTO AM 5 MM TROCAR AND IT WAS ¿TOO FORCEFUL¿ ¿ SHE COULD NOT CONFIRM IF Z-THREAD OR ADV FIX. [NAME] STATED NURSES ([NAME], [NAME] AND [NAME] WERE ALL IN ATTENDANCE ¿ NO DRS) FOUND IT ¿DANGEROUS¿ AS SHAFT WAS TOO SNUG AND HAD TO BE ¿JAMMED¿ DOWN TROCAR FOR IT TO FIT ¿ STATING IT WOULD HARM BOWEL ETC. IT ¿COULD NOT BE DONE ONE HANDED¿ COMPLAINT WAS THEN LODGED = AND QUALITY REPORTS WERE SUBMITTED. NO REASON WAS GIVEN AS TO WHY THEY DID THE PRODUCT DEMO. INTERVENTION: NA PATIENT STATUS: .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2046394 EPIX® UNIVERSAL CLIP APPLIER CLIP, IMPLANTABLE FZP APPLIED MEDICAL RESOURCES CA500 UNK 00607915125318

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown AM 5 MM TROCAR