BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CFF03, 5X100 KII FIOS ADVFIX 6/BX

    MDR report key: 9078549 · Received September 17, 2019

    Report

    Report Number
    2027111-2019-00588
    Event Type
    Malfunction
    Date Received
    September 17, 2019
    Date of Event
    August 6, 2019
    Report Date
    November 19, 2019
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    PMA / PMN Number
    K083638
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION ALONG WITH A RUBBER COMPONENT. VISUAL INSPECTION OF THE EVENT UNIT CONFIRMED THE COMPLAINANT¿S EXPERIENCE OF SEAL COMPONENT SEPARATION. THE RUBBER COMPONENT WAS IDENTIFIED AS THE DUCKBILL, A RUBBER COMPONENT OF THE SEAL. BASED ON THE CONDITION OF THE RETURNED, IT IS LIKELY THAT THE DUCKBILL WAS DISLODGED BY THE INSTRUMENTS THAT WERE INSERTED/REMOVED FROM THE TROCAR.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: HERNIA REPAIR. EVENT DESCRIPTION: THIS IS A COMPLAINT FROM THE MARKET. ADMINISTRATIVE NO. (B)(4). PLEASE REFER TO THE COMPLAINT SHEET FOR INVESTIGATION. SUBJECT OF COMPLAINT: "DDB DETACHMENT". REPORT FROM THE SALES REP: "THE DDB DROPPED INTO THE BODY CAVITY DURING THE PROCEDURE. IT WAS RECOVERED FROM THE BODY CAVITY." INITIAL INVESTIGATION REPORT BY [DISTRIBUTOR]: "THE EVENT UNIT WAS RETURNED TO [DISTRIBUTOR] AND VISUALLY INSPECTED. THE DDB WAS DETACHED. NO VISUAL DAMAGE WAS FOUND IN THE SEPTUM AND SHIELD. THE UNIT WILL BE RETURNED TO AMR FOR FURTHER EVALUATION. ADMIN# (B)(4)." PER THE COMPONENT LIST, THE DUCKBILL AND THE CANNULA WILL BE RETURNING. INTERVENTION: IT WAS RECOVERED FROM THE BODY CAVITY. PATIENT STATUS: "NO PATIENT INJURY".

    Additional Manufacturer Narrative · 1

    THE EVENT UNIT IS ANTICIPATED TO RETURN TO APPLIED MEDICAL FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    PROCEDURE PERFORMED: HERNIA REPAIR. EVENT DESCRIPTION: THIS IS A COMPLAINT FROM THE MARKET. ADMINISTRATIVE NO. (B)(4). PLEASE REFER TO THE COMPLAINT SHEET FOR INVESTIGATION. SUBJECT OF COMPLAINT: "DDB DETACHMENT." REPORT FROM THE SALES REP: "THE DDB DROPPED INTO THE BODY CAVITY DURING THE PROCEDURE. IT WAS RECOVERED FROM THE BODY CAVITY." INITIAL INVESTIGATION REPORT BY [DISTRIBUTOR]: "THE EVENT UNIT WAS RETURNED TO [DISTRIBUTOR] AND VISUALLY INSPECTED. THE DDB WAS DETACHED. NO VISUAL DAMAGE WAS FOUND IN THE SEPTUM AND SHIELD. THE UNIT WILL BE RETURNED TO AMR FOR FURTHER EVALUATION. ADMIN# (B)(4)." PER THE COMPONENT LIST, THE DUCKBILL AND THE CANNULA WILL BE RETURNING. INTERVENTION: IT WAS RECOVERED FROM THE BODY CAVITY. PATIENT STATUS: "NO PATIENT INJURY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    871591 CFF03, 5X100 KII FIOS ADVFIX 6/BX LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL RESOURCES CFF03 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1