BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    (01)00607915125318(17)260626(30)01(10)1495840

    MDR report key: 18062344 · Received November 2, 2023

    Report

    Report Number
    2027111-2023-00696
    Event Type
    Malfunction
    Date Received
    November 2, 2023
    Date of Event
    October 23, 2023
    Report Date
    May 24, 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
    AL, US
    Reporter Occupation
    003

    Narratives

    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.

    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, #(B)(4), WAS INCLUDED IN THE RECALL.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY EVENT DESCRIPTION: TWO CA500 LOT #1495840 COMPLAINTS OCCURRED DURING THE SAME PROCEDURE: (B)(4). BOTH DEVICES MISFIRED. THERE WERE "LOTS OF TENSION" AND THE CLIPS WERE NOT CLOSING COMPLETELY. THE ISSUE WAS INITIALLY OBSERVED WHEN THE FIRST CLIP WAS LOADED. THE SURGEON TRIED TO FIRE ABOUT THREE TIMES WITH NO SUCCESS BEFORE OPENING ANOTHER DEVICE. THE SAME ISSUE OCCURRED WITH THE SECOND DEVICE. THE SURGEON OPENED UP A THIRD CA500 DEVICE TO COMPLETE THE CASE. A 5 MM ADVANCED FIXATION TROCAR WAS USED. A CLIP SAT PROPERLY INTO THE JAWS. NO PRESSURE WAS APPLIED TO THE TRIGGER WHILE MOVING THROUGH THE TROCAR. NO CLIP WAS LOADED INTO THE JAWS PRIOR TO THE DEVICE¿S INSERTION/REMOVAL THROUGH THE TROCAR. NO CLIP WAS MANUALLY REMOVED AS A LOADED CLIP. THE TRIGGER APPEARED INTACT. THE CLIP FULLY LOADED INTO THE JAWS UPON ACTUATION. THE TRIGGER WAS SQUEEZED ¿PLASTIC TO PLASTIC". THE SURGEON FULLY SKELETONIZED THE VESSEL PRIOR TO USING THE CLIP APPLIER. THE SURGEON DID NOT USE THE CLIP APPLIER TO SKELETONIZE TISSUE. THE APEX OF THE CLIP WOULD NOT CLOSE. PHOTOS ARE AVAILABLE. NO PATIENT INJURY. PRODUCTS ARE AVAILABLE FOR RETURN. PATIENT STATUS: NO PATIENT INJURY. INTERVENTION: THE SURGEON OPENED UP A THIRD CA500 DEVICE TO COMPLETE THE CASE.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY. EVENT DESCRIPTION: TWO CA500 LOT #1495840 COMPLAINTS OCCURRED DURING THE SAME PROCEDURE: COMPLAINT 1 OF 2: (B)(4). COMPLAINT 2 OF 2: (B)(4). BOTH DEVICES MISFIRED. THERE WERE "LOTS OF TENSION" AND THE CLIPS WERE NOT CLOSING COMPLETELY. THE ISSUE WAS INITIALLY OBSERVED WHEN THE FIRST CLIP WAS LOADED. THE SURGEON TRIED TO FIRE ABOUT THREE TIMES WITH NO SUCCESS BEFORE OPENING ANOTHER DEVICE. THE SAME ISSUE OCCURRED WITH THE SECOND DEVICE. THE SURGEON OPENED UP A THIRD CA500 DEVICE TO COMPLETE THE CASE. A 5 MM ADVANCED FIXATION TROCAR WAS USED. A CLIP SAT PROPERLY INTO THE JAWS. NO PRESSURE WAS APPLIED TO THE TRIGGER WHILE MOVING THROUGH THE TROCAR. NO CLIP WAS LOADED INTO THE JAWS PRIOR TO THE DEVICE¿S INSERTION/REMOVAL THROUGH THE TROCAR. NO CLIP WAS MANUALLY REMOVED AS A LOADED CLIP. THE TRIGGER APPEARED INTACT. THE CLIP FULLY LOADED INTO THE JAWS UPON ACTUATION. THE TRIGGER WAS SQUEEZED ¿PLASTIC TO PLASTIC". THE SURGEON FULLY SKELETONIZED THE VESSEL PRIOR TO USING THE CLIP APPLIER. THE SURGEON DID NOT USE THE CLIP APPLIER TO SKELETONIZE TISSUE. THE APEX OF THE CLIP WOULD NOT CLOSE. PHOTOS ARE AVAILABLE. NO PATIENT INJURY. PRODUCTS ARE AVAILABLE FOR RETURN. PATIENT STATUS: NO PATIENT INJURY. INTERVENTION: THE SURGEON OPENED UP A THIRD CA500 DEVICE TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2111988 (01)00607915125318(17)260626(30)01(10)1495840 CLIPS, IMPLANTABLE FZP APPLIED MEDICAL RESOURCES CA500 1495840 00607915125318

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 5 MM ADVANCED FIXATION TROCAR