BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MILLENNIUM

    MDR report key: 16709522 · Received April 10, 2023

    Report

    Report Number
    1216677-2023-00063
    Event Type
    Injury
    Date Received
    April 10, 2023
    Date of Event
    March 1, 2023
    Report Date
    June 2, 2023
    Manufacturer
    AVALIGN TECHNOLOGIES, INC.
    Product Code
    GCJ
    PMA / PMN Number
    K980123
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE DETAILS REPORTED ON MW5115986 .

    Additional Manufacturer Narrative · 0

    UPON INVESTIGATION OF THE COMPLAINT, IT HAS BEEN DETERMINED A COOPER SURGICAL DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE DEVICE(S) INVOLVED IN THE EVENT ARE COMPETITOR PRODUCT. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED. UPON RECEIPT OF MEDWATCH REPORT MW5115986, MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE REPORTER FOR ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION WAS RECEIVED. INVESTIGATION OF THE COMPLAINT REVEALED THAT THE MODEL NUMBER PROVIDED DID NOT MATCH ANY COOPER SURGICAL DEVICES. HOWEVER, THE PROVIDED MODEL DOES CORRESPOND TO A SIMILAR MILLENNIUM DEVICE. DUE TO THE SPECIFIED MODEL NUMBER, IT HAS BEEN DETERMINED THROUGH INVESTIGATION THAT THE DEVICE REPORTED WAS A MILLENNIUM DEVICE. A COPY OF MW5115986 AND THIS REPORT HAS BEEN FORWARDED TO MILLENNIUM SURGICAL AND AVALIGN TECHNOLOGIES.

    Description of Event or Problem · 0

    AS PER DETAILS REPORTED ON MEDWATCH MW5115986. INCIDENT REPORT: "SURGEON WAS BEGINNING TO CLOSE PORT SITES WHEN A PIECE OF THE CARTER-THOMASON INSTRUMENT BROKE OFF. THE SURGEON TRIED TO FIND IT LAPAROSCOPICALLY BUT WAS UNABLE TO. C-ARM WAS BROUGHT IN TO DETECT THE PIECE WITH FLUORO. THEY IDENTIFIED IT IN THE SUBCUTANEOUS TISSUE, BUT WAS UNABLE TO RETRIEVE IT."

    Description of Event or Problem · 0

    UPON INVESTIGATION OF THE COMPLAINT, IT HAS BEEN DETERMINED A COOPER SURGICAL DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE DEVICE(S) INVOLVED IN THE EVENT ARE COMPETITOR PRODUCT. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1868203 MILLENNIUM LAPAROSCOPIC TROCAR INCISION CLOSURE REUSABLE SYSTEM GCJ AVALIGN TECHNOLOGIES, INC. 72-5220341C NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O| H