BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYN ROBOTIC PACK

    MDR report key: 20580081 · Received October 31, 2024

    Report

    Report Number
    3003419114-2024-00004
    Event Type
    Injury
    Date Received
    October 31, 2024
    Date of Event
    October 4, 2024
    Report Date
    November 22, 2024
    Manufacturer
    AMERICAN CONTRACT SYSTEMS
    Product Code
    FDE
    UDI-DI
    00191072215130
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE EVENT WAS NOT RETURNED FOR EVALUATION. THE MANUFACTURER, JIANGSU GUANDA MEDICAL, HAS RESPONDED TO SUPPLIER CORRECTIVE ACTION REQUEST. THE SUPPLIER INDICATED THEY HAVE NO INVENTORY OF THE COMPONENT, 731-B4, LOT 2402GD27B IN WAREHOUSE. THE RETAINED SAMPLE FROM COMPLAINT LOT WAS REVIEWED, NO LINTING ISSUE WAS OBSERVED. THE DEVICE HISTORY RECORD WAS REVIEWED, RECORDS WERE FOUND TO BE CONFORMING, AND PRODUCT WAS DOCUMENTED AS MEETING ALL SPECIFICATIONS PRIOR TO RELEASE. THERE IS NO UPWARD TREND FOR THIS INCIDENT TYPE. THE MANUFACTURER HAS RETRAINED STAFF ON NOVEMBER 11, 2024, ON THE "FOLDING AND FINISHING" AND "ORGANIZE PROCESS INSPECTION" PROCEDURES TO ENSURE TEAMMATES ARE APPROPRIATELY INSPECTING TOWELS FOR LINT DURING INSPECTION AND FOLDING PROCESSES. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE EVENT WAS NOT RETURNED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION. AMERICAN CONTRACT SYSTEM IS A CONVENIENCE KIT MANUFACTURER. THE COMPLAINT COMPONENT IS MANUFACTURED BY MEDICAL ACTION INDUSTRIES PART NUMBER 731-B4. (REGISTRATION NUMBER: 1030451). THE MANUFACTURER HAS BEEN NOTIFIED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BLUE FIBERS WERE FOUND ON PATIENT'S SKIN AND IN THE SURGICAL SITE (ABDOMEN) DURING SURGERY. ADDITIONAL INFORMATION WAS RECEIVED ON OCTOBER 14, 2024, THE CUSTOMER RESPONDED THE SURGERY WAS A ROBOTIC HYSTERECTOMY. THE FIBERS WERE IRRIGATED AND SUCTIONED FROM SITE/SKIN WITH NO OTHER IMPACT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED TO GET COMPONENT INFORMATION FROM THE CUSTOMER ON OCTOBER 11, 2024, OCTOBER 14, 2024, AND OCTOBER 15, 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1897010 GYN ROBOTIC PACK LAPAROSCOPY KIT FDE AMERICAN CONTRACT SYSTEMS EVRB95H 12-7155711 00191072215130

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other