BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 14112944 · Received April 14, 2022

    Report

    Report Number
    2027111-2022-00558
    Event Type
    Malfunction
    Date Received
    April 14, 2022
    Date of Event
    December 16, 2021
    Report Date
    June 7, 2022
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    UDI-DI
    00607915123550
    PMA / PMN Number
    K041795
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. AS THE EVENT UNIT WAS NOT RETURNED, APPLIED MEDICAL IS UNABLE TO DETERMINE IF THE EVENT UNIT EXHIBITED ANY NON-CONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. IN THE ABSENCE OF THE EVENT UNIT, IT IS DIFFICULT TO DETERMINE IF THE REPORTED EVENT WAS CAUSED BY A MANUFACTURING NON-CONFORMANCE OR CIRCUMSTANTIAL FACTORS AT THE TIME OF USE. APPLIED MEDICAL HAS REVIEWED THE DETAILS SURROUNDING THE EVENT AND IS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE EVENT. 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: UNKNOWN. EVENT DESCRIPTION: A FAULT HAS OCCURRED WITH ITEM SKU 153343, REF: CTF03, LOT: 1411612, SUPPLIED FROM THE NDC. ON (B)(6) 2021 DURING THE THORACIC PART OF THE PROCEDURE IT WAS NOTICED THAT THE TIP OF 5MM TROCAR WAS MISSING. PRESUMED IN PATIENT BUT NOT FOUND DUE TO SMALL SIZE AND PLASTIC , NOT SHOW ON XRAY. EXPIRY DATE OF PRODUCT MARCH 2024. PATIENT STATUS: NO PATIENT INJURY HAS BEEN REPORTED

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: COMPLAINT 1 OF 5: (B)(4) [MFR REPORT # 2027111 - 2022 - 00557]; COMPLAINT 2 OF 5: (B)(4) [MFR REPORT # 2027111 - 2022 - 00558]; COMPLAINT 3 OF 5: (B)(4) [MFR REPORT # 2027111 - 2022 - 00596]; COMPLAINT 4 OF 5: (B)(4) [MFR REPORT # 2027111 - 2022 - 00597]; COMPLAINT 5 OF 5: (B)(4) [MFR REPORT # 2027111 - 2022 - 00598]. A FAULT HAS OCCURRED WITH ITEM SKU 153343, REF: (B)(4), LOT: 1411612, SUPPLIED FROM THE NDC. ON (B)(6) 2021 DURING THE THORACIC PART OF THE PROCEDURE IT WAS NOTICED THAT THE TIP OF 5MM TROCAR WAS MISSING. PRESUMED IN PATIENT BUT NOT FOUND DUE TO SMALL SIZE AND PLASTIC , NOT SHOW ON XRAY. EXPIRY DATE OF PRODUCT MARCH 2024. NO OF INSTANCES: 2-5. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON 21APR22: I HAVE TRIED TO FOLLOW UP WITH THIS AND NO ONE WILL RESPOND TO ME. PATIENT STATUS: NO PATIENT INJURY HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1639486 CTF03, 5X100 KII FIOS Z-THR 6/BX LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL RESOURCES CTF03 1411612 00607915123550

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose