BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALEXIS O WOUND PROTECTOR-RETRACTOR

    MDR report key: 20262804 · Received September 19, 2024

    Report

    Report Number
    2027111-2024-00834
    Event Type
    Malfunction
    Date Received
    September 19, 2024
    Date of Event
    August 28, 2024
    Report Date
    March 20, 2025
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    KGW
    UDI-DI
    00607915117252
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT IS ANTICIPATED TO RETURN. 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 CONFIRMED THE COMPLAINANT¿S EXPERIENCE OF THE INNER RING SEPARATING FROM THE SHEATH. BASED ON THE CONDITION OF THE RETURNED UNIT AND THE DESCRIPTION OF THE EVENT, IT IS LIKELY THAT THE SHEATH WAS NOT PROPERLY HEAT SEALED TO THE RING, CAUSING A WEAK OR INCOMPLETE FILM-TO-RING SEAL. APPLIED MEDICAL HAS PERFORMED A HISTORICAL TREND ANALYSIS AND REVIEW OF PRODUCTION RECORDS AND NO TRENDS WERE IDENTIFIED. [CORRECTION] THE BRAND NAME IN SECTION D1 AND THE PRIMARY UDI NUMBER IN SECTION D4 HAVE BEEN UPDATED.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: VATS. DESCRIPTION OF EVENT: COMPLAINT 1 OF 2: (B)(4) MODEL C8401 LOT 1506767 (B)(6) EA. COMPLAINT 2 OF 2: (B)(4) MODEL C8401 LOT 1506767 (B)(6) EA. TWO DEVICE MALFUNCTIONS OCCURRED DURING THE SAME PROCEDURE. [HOSPITAL] I¿M HERE AT THE [FACILITY] IN ANOTHER VATS CASE. 2 MORE ALEXIS TORE AT THE RING. SAME LOT NUMBER AS THE PREVIOUS ONE: LOT # 1506767. ADDITIONAL INFORMATION RECEIVED FROM ACCOUNT MANAGER VIA EMAIL ON 28AUG2024: THEY ARE GOING TO SAVE THE 2 FROM TODAY TO SEND BACK TO CORPORATE THE PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED FROM ACCOUNT MANAGER VIA EMAIL ON 29AUG2024: NO PATIENT INJURY OCCURRED. THE SURGEON OPENED A NEW ALEXIS TO COMPLETE THE PROCEDURE. THE FIRST ALEXIS SHEATH TORE MID-PROCEDURE. THE SECOND ALEXIS TORE MID-PROCEDURE. SUCTION, BOVIE, AND STAPLER WERE USED WITHIN THE ALEXIS. THE SHEATH DID NOT PARTICULATE. ADDITIONAL INFORMATION RECEIVED FROM ACCOUNT MANAGER VIA EMAIL ON 29AUG2024: THEY WILL RETURN THE 2 ALEXIS THAT WERE USED IN THE CASE YESTERDAY. INTERVENTION: THE SURGEON OPENED A NEW ALEXIS TO COMPLETE THE PROCEDURE. PATIENT STATUS: NO PATIENT INJURY.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: VATS DESCRIPTION OF EVENT: COMPLAINT 1 OF 2: (B)(4) MODEL C8401 LOT 1506767 1EA - MFR# 2027111-2024-00833. COMPLAINT 2 OF 2: (B)(4) MODEL C8401 LOT 1506767 1EA - MFR# 2027111-2024-00834. TWO DEVICE MALFUNCTIONS OCCURRED DURING THE SAME PROCEDURE. [HOSPITAL]: I¿M HERE AT THE [FACILITY] IN ANOTHER VATS CASE. 2 MORE ALEXIS TORE AT THE RING. SAME LOT NUMBER AS THE PREVIOUS ONE: LOT # 1506767. ADDITIONAL INFORMATION RECEIVED FROM ACCOUNT MANAGER VIA EMAIL ON 28AUG2024: THEY ARE GOING TO SAVE THE 2 FROM TODAY TO SEND BACK TO CORPORATE THE PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED FROM ACCOUNT MANAGER VIA EMAIL ON 29AUG2024: NO PATIENT INJURY OCCURRED. THE SURGEON OPENED A NEW ALEXIS TO COMPLETE THE PROCEDURE. THE FIRST ALEXIS SHEATH TORE MID-PROCEDURE. THE SECOND ALEXIS TORE MID-PROCEDURE. SUCTION, BOVIE, AND STAPLER WERE USED WITHIN THE ALEXIS. THE SHEATH DID NOT PARTICULATE. ADDITIONAL INFORMATION RECEIVED FROM ACCOUNT MANAGER VIA EMAIL ON 29AUG2024: THEY WILL RETURN THE 2 ALEXIS THAT WERE USED IN THE CASE YESTERDAY. INTERVENTION: THE SURGEON OPENED A NEW ALEXIS TO COMPLETE THE PROCEDURE. PATIENT STATUS: NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223927 ALEXIS O WOUND PROTECTOR-RETRACTOR RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL KGW APPLIED MEDICAL RESOURCES C8401 1506767 00607915117252

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SUCTION, BOVIE, AND STAPLER