BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX

    MDR report key: 19615672 · Received June 26, 2024

    Report

    Report Number
    2027111-2024-00713
    Event Type
    Malfunction
    Date Received
    June 26, 2024
    Date of Event
    June 10, 2024
    Report Date
    November 26, 2024
    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
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. TESTING WAS PERFORMED ON THE EVENT UNIT, WHICH CONFIRMED THE USER¿S EXPERIENCE OF NO CLIP LOADED. VISUAL INSPECTION WAS PERFORMED WHERE NO RELEVANT NON-CONFORMANCES WERE IDENTIFIED. 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. THE PROBABILITY AND CRITICALITY OF HARM RESULTING FROM THIS FAILURE HAVE BEEN EVALUATED AND WERE FOUND TO BE AT AN ACCEPTABLE LEVEL.

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT IS ANTICIPATED TO RETURN TO APPLIED MEDICAL. A FOLLOW UP REPORT WILL BE PROVIDED FOLLOWING THE COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY. EVENT DESCRIPTION: DR. [NAME] WAS PERFORMING A LAPAROSCOPIC CHOLECYSTECOMY ON MONDAY, JUNE 10, 2024 AT [HOSPITAL]. DR. [NAME] INTRODUCED THE CLIP APPLIER THROUGH AN 11 MM APPLIED TROCAR (CFR33). WHEN ATTEMPTING TO DELIVER THE FIRST CLIP, DR. [NAME] ACTUATED THE HANDLE. THE JAWS OF THE CLIP APPLIER CLOSED AROUND THE VESSEL, AND AFTER A FULL PLASTIC TO PLASTIC SQUEEZE, THE JAWS RELEASED AND NO CLIP WAS APPLIED. DR. [NAME] THEN TRIED 5 MORE TIMES TO DELIVER A CLIP TO THE VESSEL. EACH SUBSEQUENT TIME, NO CLIP WAS DELIVERED TO THE JAWS. THE SCRUB TECHNICIAN WAS HANDED THE HANDPIECE AFTER A NEW CLIP APPLIER WAS OPENED BY THE CIRCULATOR. THE SCRUB TECHNICIAN ACTUATED THE HANDLE AND A CLIP WAS DELIVERED AND FIRED. THIS WAS REPEATED 3 MORE TIMES FOR A TOTAL OF 4 CLIPS FIRED. THE CLIP APPLIER WAS SET ASIDE AND PREPARED TO BE SENT BACK TO APPLIED AS DEFECTIVE. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 12JUN2024 VIA EMAIL: ¿ PLEASE ADVISE IF THE RETURN BOX SHOULD BE SHIPPED TO YOURSELF OR THE HOSPITAL. ¿ PLEASE PROVIDE A NO CHARGE PO FOR THE REPLACEMENT. ¿ I WILL PROVIDE THIS AS SOON AS I HAVE IT. ¿ WHEN THE CLIP WAS LOADED AND VISIBLE BETWEEN THE JAWS OF THE DEVICE, WAS IT PROPERLY SEATED? YES. ¿ WAS A CLIP LOADED INTO THE JAWS PRIOR TO THE DEVICE¿S INSERTION/REMOVAL THROUGH THE TROCAR? NO. O IF SO, WAS THE ACTUATION COMPLETED BY FULLY SQUEEZING THE TRIGGER AND ALLOWING THE DEVICE TO REST? ¿ WAS A LOADED CLIP MANUALLY REMOVED FROM THE JAWS? NO O IF SO, WAS THE DEVICE ACTUATED AND RESET? ¿ COULD THE TRIGGER BE EASILY AND COMPLETELY ACTUATED? OR WAS THERE RESISTANCE IN TRIGGER ACTUATION? I WAS NOT TOLD OF ANY DIFFERENCE IN RESISTANCE WHEN THE TRIGGER WAS ACTUATED. PATIENT STATUS: STABLE. INTERVENTION: THE CASE WAS COMPLETED WITH A NEW ONE.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY EVENT DESCRIPTION: DR. [NAME] WAS PERFORMING A LAPAROSCOPIC CHOLECYSTECOMY ON MONDAY, ON (B)(6) 2024 AT [HOSPITAL]. DR. [NAME] INTRODUCED THE CLIP APPLIER THROUGH AN 11 MM APPLIED TROCAR (CFR33). WHEN ATTEMPTING TO DELIVER THE FIRST CLIP, DR. [NAME] ACTUATED THE HANDLE. THE JAWS OF THE CLIP APPLIER CLOSED AROUND THE VESSEL, AND AFTER A FULL PLASTIC TO PLASTIC SQUEEZE, THE JAWS RELEASED AND NO CLIP WAS APPLIED. DR. [NAME] THEN TRIED 5 MORE TIMES TO DELIVER A CLIP TO THE VESSEL. EACH SUBSEQUENT TIME, NO CLIP WAS DELIVERED TO THE JAWS. THE SCRUB TECHNICIAN WAS HANDED THE HANDPIECE AFTER A NEW CLIP APPLIER WAS OPENED BY THE CIRCULATOR. THE SCRUB TECHNICIAN ACTUATED THE HANDLE AND A CLIP WAS DELIVERED AND FIRED. THIS WAS REPEATED 3 MORE TIMES FOR A TOTAL OF 4 CLIPS FIRED. THE CLIP APPLIER WAS SET ASIDE AND PREPARED TO BE SENT BACK TO APPLIED AS DEFECTIVE. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 12JUN2024 VIA EMAIL: PLEASE ADVISE IF THE RETURN BOX SHOULD BE SHIPPED TO YOURSELF OR THE HOSPITAL. PLEASE PROVIDE A NO CHARGE PO FOR THE REPLACEMENT. ¿ I WILL PROVIDE THIS AS SOON AS I HAVE IT. WHEN THE CLIP WAS LOADED AND VISIBLE BETWEEN THE JAWS OF THE DEVICE, WAS IT PROPERLY SEATED? YES WAS A CLIP LOADED INTO THE JAWS PRIOR TO THE DEVICE¿S INSERTION/REMOVAL THROUGH THE TROCAR? NO IF SO, WAS THE ACTUATION COMPLETED BY FULLY SQUEEZING THE TRIGGER AND ALLOWING THE DEVICE TO REST? WAS A LOADED CLIP MANUALLY REMOVED FROM THE JAWS? NO IF SO, WAS THE DEVICE ACTUATED AND RESET? COULD THE TRIGGER BE EASILY AND COMPLETELY ACTUATED? OR WAS THERE RESISTANCE IN TRIGGER ACTUATION? I WAS NOT TOLD OF ANY DIFFERENCE IN RESISTANCE WHEN THE TRIGGER WAS ACTUATED. PATIENT STATUS: STABLE INTERVENTION: THE CASE WAS COMPLETED WITH A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578658 CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX CLIP, IMPLANTABLE FZP APPLIED MEDICAL RESOURCES CA500 1509497 00607915125318

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 11 MM APPLIED TROCAR (CFR33).