BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENERAL SURGICAL PROCEDURE KIT

    MDR report key: 19615648 · Received June 26, 2024

    Report

    Report Number
    3007069947-2024-00001
    Event Type
    Injury
    Date Received
    June 26, 2024
    Date of Event
    June 13, 2024
    Report Date
    August 14, 2024
    Manufacturer
    AMERICAN CONTRACT SYSTEMS, INC.
    Product Code
    FDE
    UDI-DI
    00191072204929
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT PHOTO WAS RECEIVED AND REVIEWED. BASED ON REVIEW OF THE PHOTO, IT APPEARS THE ASSEMBLY TEAMMATE WRAPPED THE PACK TOO TIGHT. ASSEMBLY TEAM WAS RETRAINED ON AS-04, WRAPPING TECHNIQUES. WHEN THE PACK IS WRAPPED TOO TIGHT IT CAN CAUSE COMPONENTS TO POKE THROUGH THE WRAP. A QUALITY ALERT WAS ISSUED AND REVIEWED ADDITIONALLY WITH TEAMMATES FOR THIS COMPLAINT. THE DEVICE HISTORY RECORD WAS PULLED AND REVIEWED. NO ISSUES WERE FOUND. THE ROOT CAUSE IS DUE TO ASSEMBLY TEAMMATE NOT PAYING CLOSE ATTENTION TO DETAIL. 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. 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

    A HOLE IN TABLE COVER WAS DETECTED PRIOR TO USE ON PATIENT; HOWEVER, THE SURGICAL CASE HAD TO BE CANCELLED. ADDITIONAL FOLLOW UP QUESTIONS HAVE BEEN REQUESTED; NO RESPONSES HAVE BEEN RECEIVED TO-DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577662 GENERAL SURGICAL PROCEDURE KIT LAPAROSCROPY KIT FDE AMERICAN CONTRACT SYSTEMS, INC. RCLC51A 892241 00191072204929

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other