BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD004, 12/15MM RETRIEVAL SYSTEM, 5/BX

    MDR report key: 19669289 · Received July 3, 2024

    Report

    Report Number
    2027111-2024-00723
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    June 13, 2024
    Report Date
    November 4, 2024
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    UDI-DI
    00607915126773
    PMA / PMN Number
    K060051
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. VISUAL INSPECTION CONFIRMED THE COMPLAINANT¿S EXPERIENCE OF HOLES ON THE PROXIMAL PORTION OF THE BAG. STRETCHING WAS ALSO OBSERVED NEAR THE HOLES. BASED ON THE CONDITION OF THE RETURNED UNIT AND THE DESCRIPTION OF THE EVENT, IT IS LIKELY THAT THE REPORTED EVENT WAS CAUSED BY EXCESS FORCE BEING APPLIED ON THE TISSUE BAG WITH A BLUNT INSTRUMENT OR OBJECT. A HISTORICAL TREND ANALYSIS AND REVIEW OF PRODUCTION RECORDS WAS PERFORMED, AND NO RELEVANT DOCUMENTATION WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: LDG. EVENT DESCRIPTION: [HOSPITAL]. DEALER: [NAME]. REPORT FROM THE SALES REP VIA EMAIL; WHEN THE POUCH WAS SPREAD IN THE ABDOMINAL CAVITY, A HOLE WAS FOUND. INTERVENTION: REPLACED TO A HOSPITAL INVENTORY NEW CD004 AND THE PROCEDURE WAS COMPLETED. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: LDG. EVENT DESCRIPTION: [HOSPITAL]. DEALER: [NAME]. REPORT FROM THE SALES REP VIA EMAIL; WHEN THE POUCH WAS SPREAD IN THE ABDOMINAL CAVITY, A HOLE WAS FOUND. INTERVENTION: REPLACED TO A HOSPITAL INVENTORY NEW CD004 AND THE PROCEDURE WAS COMPLETED. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977617 CD004, 12/15MM RETRIEVAL SYSTEM, 5/BX LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL RESOURCES CD004 1505466 00607915126773

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown