BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX

    MDR report key: 18124538 · Received November 13, 2023

    Report

    Report Number
    2027111-2023-00727
    Event Type
    Malfunction
    Date Received
    November 13, 2023
    Date of Event
    October 17, 2023
    Report Date
    July 11, 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
    OH, US
    Reporter Occupation
    003

    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, #1491910, WAS INCLUDED IN THE RECALL.

    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: THREE CA500 COMPLAINTS OCCURRED DURING THE SAME CASE AT [HOSPITAL]: COMPLAINT 1 OF 3: 2023-003183 - CA500, LOT #: 1491910. COMPLAINT 2 OF 3: 2023-003184 - CA500, LOT #: 1491910. COMPLAINT 3 OF 3: 2023-003209. STANDARD USAGE DURING A LAP CHOLE PROCEDURE. SQUEEZE THE HANDLE AND THE CLIP DOES NOT COME OUT. IF THE CLIP DOES COME OUT, IT DOESN'T APPROXIMATE CORRECTLY AND FALLS OFF OR NEEDS TO BE REMOVED. NO CLINICAL IMPACT TO THE PATIENT AS A RESULT OF THE EVENT. THEY HAD TO OPEN A NEW CLIP APPLIER. NO OTHER INSTRUMENTS WERE USED WHEN THE COMPLAINT EVENT OCCURRED. NO PATIENT INJURY OR ILLNESS OCCURRED ASSOCIATED WITH THE COMPLAINT EVENT. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 20OCT2023 FROM [NAME], ACCOUNT MANAGER I, APPLIED MEDICAL ALL 3 CLIP APPLIERS MALFUNCTIONED IN THE SAME CASE. JUST THIS TUESDAY, 3 CLIP APPLIERS HAD ISSUES DURING ONE PROCEDURE. SO, THEY HAD TO OPEN 4 UNITS TO COMPLETE ONE LAP CHOLE. THE DOC FIRES 2 CLIPS JUST FINE AND THEN NOTHING. SOMETIMES HE CLICKS THE HANDLE BUT THERE IS NO CLIP IN THE JAWS. A FEW TIMES, HE WAS UNABLE TO SQUEEZE THE HANDLE. SOMETIMES HE HAS TO CLICK THE HANDLE A FEW TIMES JUST TO GET ONE CLIP TO COME OUT. THERE HAS NOT BEEN AN ISSUE WITH THE CLIP'S PURCHASE ON THE TISSUE. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS OCCURRED ASSOCIATED WITH THE COMPLAINT EVENT. INTERVENTION: THEY HAD TO OPEN 4 UNITS TO COMPLETE ONE LAP CHOLE.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY EVENT DESCRIPTION: THREE CA500 COMPLAINTS OCCURRED DURING THE SAME CASE AT [HOSPITAL]: COMPLAINT 1 OF 3: (B)(4), LOT #1491910; COMPLAINT 2 OF 3: (B)(4)- CA500 LOT #1491910; COMPLAINT 3 OF 3: (B)(4). STANDARD USAGE DURING A LAP CHOLE PROCEDURE. SQUEEZE THE HANDLE AND THE CLIP DOES NOT COME OUT. IF THE CLIP DOES COME OUT, IT DOESN'T APPROXIMATE CORRECTLY AND FALLS OFF OR NEEDS TO BE REMOVED. NO CLINICAL IMPACT TO THE PATIENT AS A RESULT OF THE EVENT. THEY HAD TO OPEN A NEW CLIP APPLIER. NO OTHER INSTRUMENTS WERE USED WHEN THE COMPLAINT EVENT OCCURRED. NO PATIENT INJURY OR ILLNESS OCCURRED ASSOCIATED WITH THE COMPLAINT EVENT. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 20OCT2023 FROM [NAME], ACCOUNT MANAGER I, APPLIED MEDICAL ALL 3 CLIP APPLIERS MALFUNCTIONED IN THE SAME CASE. JUST THIS TUESDAY, 3 CLIP APPLIERS HAD ISSUES DURING ONE PROCEDURE. SO, THEY HAD TO OPEN 4 UNITS TO COMPLETE ONE LAP CHOLE. THE DOC FIRES 2 CLIPS JUST FINE AND THEN NOTHING. SOMETIMES HE CLICKS THE HANDLE BUT THERE IS NO CLIP IN THE JAWS. A FEW TIMES, HE WAS UNABLE TO SQUEEZE THE HANDLE. SOMETIMES HE HAS TO CLICK THE HANDLE A FEW TIMES JUST TO GET ONE CLIP TO COME OUT. THERE HAS NOT BEEN AN ISSUE WITH THE CLIP'S PURCHASE ON THE TISSUE. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS OCCURRED ASSOCIATED WITH THE COMPLAINT EVENT. INTERVENTION: THEY HAD TO OPEN 4 UNITS TO COMPLETE ONE LAP CHOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1973598 CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX CLIP, IMPLANTABLE FZP APPLIED MEDICAL RESOURCES CA500 1491910 00607915125318

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown