BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX

    MDR report key: 7363788 · Received March 22, 2018

    Report

    Report Number
    2027111-2018-00118
    Event Type
    Malfunction
    Date Received
    March 22, 2018
    Date of Event
    February 22, 2018
    Report Date
    May 14, 2018
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    FZP
    UDI-DI
    00607915125318
    PMA / PMN Number
    K011236
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. VISUAL INSPECTION CONFIRMED THAT THE FEEDER, A METAL COMPONENT LOCATED IN THE SHAFT, WAS DAMAGED. BASED ON THE CONDITION OF THE RETURNED UNIT, IT IS LIKELY THAT THE REPORTED EVENT WAS CAUSED BY THE DAMAGED FEEDER. THE INSTRUCTIONS FOR USE (IFU) STATES "DO NOT PLACE THE CLIP APPLIER THROUGH THE TROCAR IF A CLIP IS PRESENT IN THE JAWS. DOING SO MAY RESULT IN DAMAGE TO THE DEVICE..." THE PROBABILITY AND CRITICALITY OF HARM RESULTING FROM THIS FAILURE HAVE BEEN EVALUATED AND WERE FOUND TO BE AT AN ACCEPTABLE LEVEL. APPLIED MEDICAL WILL CONTINUE TO MONITOR ITS VIGILANCE SYSTEM FOR TRENDS AND TAKE APPROPRIATE ACTIONS, AS NECESSARY, TO ENSURE THE PERFORMANCE AND SAFETY OF ITS PRODUCTS.

    Description of Event or Problem · 1

    PROCEDURE PERFORMED: LAP CHOLECYSTECTOMY. THE SURGEON WAS USING THE CA500 UNIVERSAL CLIP APPLIER. DURING A LAP CHOLECYSTECTOMY. THE INSERTION INTO A 5 MM TROCAR (CFF03) WAS NOT SMOOTH, QUITE TOUGH TO PUT IN. 8 CLIPS WERE FIRED ON TO THE DUCT AND ARTERY, 3 CLIPS THEN FELL FROM THE OPENING OF THE JAWS AND HAVE TO BE RETRIEVED FORM THE ABDOMEN, ANOTHER WAS CLIPPED ONTO THE DUCT HOWEVER THEN FELL OFF. THIS WAS ALSO RETRIEVED FROM THE ABDOMEN. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL TEAM MEMBER, 27TH FEB 2018: THE REP WORKED WITH THE REGISTRAR AGAIN TODAY AND PLEASED TO CONFIRM HE WAS HAPPY WITH THE DEVICE. HE ALSO ADVISED HE MAY HAVE PUT PRESSURE ON THE TRIGGER DESPITE THE REP IN-SERVICING NOT TO DO THIS. FURTHER INFORMATION IS THAT MISS WORKED WITH HER REG. WHO HAD THE ISSUE. THE REP EXPLAINED ABOUT THE CLIP APPLIER EVALUATION AND THEY WERE HAPPY TO USE ON CASES THEY FELT SUITABLE AS THEY NORMALLY USE THE PLASTIC CLIPS, SHE ALSO SHOWED THEM THE CLIP APPLIER AND IN-SERVICE. MISS USED IN ONE CASE AND WAS HAPPY, HER REG USED IT IN ANOTHER FOLLOWING CASE. APPLIED MEDICAL REP WAS PRESENT DURING THE CASE AND WAS TALKING THE SCRUB NURSE THROUGH TAKING THE PRODUCT OUT OF THE PACKAGING AND TALKING THE REG THROUGH THE STEPS, EXPLAINING NOT TO TOUCH THE TRIGGER WHEN INSERTING AS THIS COULD PRELOAD THE CLIP. THE CLIP APPLIER MET QUITE A LOT OF RESISTANCE UPON INSERTION INTO THE TROCAR AND THE REG COMMENTED ON THIS. CLIPS WERE FIRED ON TO THE DUCT AND ARTERY, HE THEN WANTED TO CLIP THE DUCT (GALL BLADDER SIDE OF THE CLIPS) TO FIND THE CHOLANGIOGRAM ZONE. DURING THIS TIME SEVERAL CLIPS FELL OUT OF THE CLIP APPLIER AND THESE WERE RETRIEVED FROM THE ABDOMEN. SPOKE WITH THE REG AFTER THE CASE AND EXPLAINED THE ISSUES MAY HAVE OCCURRED DUE TO SQUEEZING THE TRIGGER THUS PRE-LOADING A CLIP, HE MAINTAINED THAT HE DID NOT SQUEEZE THE TRIGGER AND PRE-LOAD A CLIP. THE REP TOOK OUT HER DEMO CLIP APPLIER, CA500, WITH A TROCAR, MOD. CFF05, AND TALKED THROUGH WHAT HAD HAPPENED, AND THE REG SHOWED HER EXACTLY WHAT HE DID. HE THOUGHT HE DID NOT PRELOAD THE CLIP DURING THIS DEMONSTRATION AND HE FELT THAT THERE WAS MORE RESISTANCE DURING THE CASE THAN WITH THE DEMO PRODUCT. THE REP TOOK OUT HER DEMO CA500 WITH A CFF05 AND TALKED THROUGH WHAT HAD HAPPENED, AND THE REG SHOWED HER EXACTLY WHAT HE DID. THE FOLLOWING DAY THE APPLIED MEDICAL REP TOOK OUT A DEMO CA500 AND CFF03 AND WENT THROUGH THE IN-SERVICE AGAIN HOWEVER DID NOT USE DURING THE CASE DUE TO PATIENT ANATOMY AND LARGE PLASTIC CLIPS NEEDING TO BE USED. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS OCCURED ASSOCIATED WITH THE COMPLAINT EVENT PROCEDURE CONTINUED AND FINISHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206648 CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX FZP FZP APPLIED MEDICAL RESOURCES CA500 1311735 00607915125318

    Patients

    Seq Age Sex Outcome Treatment
    1