BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CTF03, 5X100 KII FIOS Z-THR 6/BX

    MDR report key: 13957147 · Received March 30, 2022

    Report

    Report Number
    2027111-2022-00536
    Event Type
    Malfunction
    Date Received
    March 30, 2022
    Date of Event
    March 1, 2022
    Report Date
    June 30, 2022
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    PMA / PMN Number
    K041795
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. VISUAL INSPECTION OF THE EVENT UNIT CONFIRMED THE COMPLAINANT¿S EXPERIENCE OF SEAL COMPONENT SEPARATION. THE DUCKBILL AND SHIELD, INTERNAL COMPONENTS OF THE SEAL, WERE FOUND TO BE DISLODGED FROM THE SEAL SUBASSEMBLY. BASED ON THE CONDITION OF THE RETURNED UNIT, IT IS LIKELY THAT THE REPORTED EVENT WAS CAUSED BY NON-AXIAL INSERTION OR REMOVAL OF ASYMMETRICAL INSTRUMENTS THROUGH THE TROCAR. APPLIED MEDICAL¿S INSTRUCTIONS FOR USE (IFU) STATES THAT, "EXTRA CARE SHOULD BE USED WHEN INSERTING ANGULAR AND ASYMMETRICAL INSTRUMENTS, SUCH AS 'J' HOOKS AND CLIP APPLIERS. ALL INSTRUMENTS SHOULD BE CENTERED AXIALLY WHEN INSERTED THROUGH THE SEAL TO PREVENT TEARING." THE PROBABILITY AND CRITICALITY OF HARM RESULTING FROM THIS FAILURE HAVE BEEN EVALUATED AND WERE FOUND TO BE AT AN ACCEPTABLE LEVEL.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: CHOLECYSTECTOMY. EVENT DESCRIPTION: REPORT FROM THE SALES REP. PNEUMOPERITONEUM WAS NO LONGER MAINTAINED DURING THE PROCEDURE. THE CASE WAS COMPLETED WITH THE NEW ONE. THE SALES REP SAID THAT THE FACILITY DOES NOT DISASSEMBLE THE SEAL COMPONENT TO CHECK IT. WE WOULD LIKE TO KNOW IF THERE ARE ANY SIGNS OF DISASSEMBLY THE SEAL COMPONENT. INITIAL INVESTIGATION REPORT: THE EVENT UNIT WAS RETURNED TO US AND VISUALLY INSPECTED. DDB HAD BEEN ALREADY DETACHED ON ARRIVAL. NO VISUAL DAMAGE WAS FOUND IN THE SEPTUM, DDB. IT APPEARED THAT THERE WAS NO SHIELD. THE UNIT WILL BE RETURNED TO AMR FOR FURTHER EVALUATION. TYPE OF INTERVENTION: THE CASE WAS COMPLETED WITH THE NEW ONE. PATIENT STATUS: NO PATIENT INJURY.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: CHOLECYSTECTOMY EVENT DESCRIPTION: REPORT FROM THE SALES REP. PNEUMOPERITONEUM WAS NO LONGER MAINTAINED DURING THE PROCEDURE. THE CASE WAS COMPLETED WITH THE NEW ONE. THE SALES REP SAID THAT THE FACILITY DOES NOT DISASSEMBLE THE SEAL COMPONENT TO CHECK IT. WE WOULD LIKE TO KNOW IF THERE ARE ANY SIGNS OF DISASSEMBLY THE SEAL COMPONENT. INITIAL INVESTIGATION REPORT: THE EVENT UNIT WAS RETURNED TO US AND VISUALLY INSPECTED. DDB HAD BEEN ALREADY DETACHED ON ARRIVAL. NO VISUAL DAMAGE WAS FOUND IN THE SEPTUM, DDB. IT APPEARED THAT THERE WAS NO SHIELD. THE UNIT WILL BE RETURNED TO AMR FOR FURTHER EVALUATION. TYPE OF INTERVENTION: THE CASE WAS COMPLETED WITH THE NEW ONE. PATIENT STATUS: NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042654 CTF03, 5X100 KII FIOS Z-THR 6/BX LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL RESOURCES CTF03 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown