BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KII SLEEVE

    MDR report key: 19845085 · Received July 26, 2024

    Report

    Report Number
    2027111-2024-00762
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Date of Event
    June 27, 2024
    Report Date
    February 4, 2025
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    UDI-DI
    00607915124267
    PMA / PMN Number
    K060096
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KU
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. VISUAL INSPECTION CONFIRMED THE COMPLAINANT¿S EXPERIENCE OF A SEVERED CANNULA WING TAB WITHIN THE CANNULA SHAFT. BASED ON THE CONDITION OF THE RETURNED UNIT, THE SEVERED WING TAB DID NOT ORIGINATE FROM THE RETURNED CANNULA AS NO DAMAGES WERE OBSERVED ON THE RETURNED CANNULA¿S WING TAB. IT IS POSSIBLE THE WING TAB FOUND WITHIN THE CANNULA SHAFT BECAME LODGED WITHIN THE CANNULA SOMETIME DURING THE MANUFACTURING PROCESS. APPLIED MEDICAL HAS PERFORMED A HISTORICAL TREND ANALYSIS AND REVIEW OF PRODUCTION RECORDS AND NO RELEVANT DOCUMENTATIONS WERE IDENTIFIED. [CORRECTION] SECTIONS D1 AND D4 (PRIMARY UNIQUE DEVICE IDENTIFICATION NUMBER AND ADDITIONAL UNIQUE DEVICE IDENTIFICATION NUMBER) HAVE BEEN UPDATED.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: LAP CHOLECYSTECTOMY. EVENT DESCRIPTION: "TROCAR 11 MM Z-THREAD WAS BEING USED IN A LAP CHOLE CASE. THE SURGEON WAS TRYING TO INSERT THE INTRODUCER THROUGH THE SLEEVE WHEN HE NOTICED A SMALL PLASTIC PART STUCK IN THE MIDDLE OF THE SLEEVE. HE WAS NOT ABLE TO REMOVE IT, SO ANOTHER SLEEVE WAS OPENED. NO CLINICAL IMPACT ON THE PATIENT". INTERVENTION: A NEW SLEEVE WAS OPENED PATIENT STATUS: NO CLINICAL IMPACT ON THE PATIENT.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: LAP CHOLECYSTECTOMY. EVENT DESCRIPTION: "TROCAR 11 MM Z-THREAD WAS BEING USED IN A LAP CHOLE CASE. THE SURGEON WAS TRYING TO INSERT THE INTRODUCER THROUGH THE SLEEVE WHEN HE NOTICED A SMALL PLASTIC PART STUCK IN THE MIDDLE OF THE SLEEVE. HE WAS NOT ABLE TO REMOVE IT, SO ANOTHER SLEEVE WAS OPENED. NO CLINICAL IMPACT ON THE PATIENT". INTERVENTION: A NEW SLEEVE WAS OPENED. PATIENT STATUS: NO CLINICAL IMPACT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921979 KII SLEEVE LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL RESOURCES CTS12 UNK 00607915124267

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown