BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE

    MDR report key: 10142561 · Received June 11, 2020

    Report

    Report Number
    10142561
    Event Type
    Malfunction
    Date Received
    June 11, 2020
    Date of Event
    May 20, 2020
    Report Date
    June 1, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    DURING A LAPAROSCOPIC LEFT HEMICOLECTOMY, THE FIRST LOAD OF THE SURGICAL STAPLER WORKED AS EXPECTED, BUT THE SECOND LOAD DID NOT WORK PROPERLY. IT FIRED AND CUT ONLY HALFWAY THEN GOT JAMMED. A THIRD LOAD WAS USED TO COMPLETE THE ORIGINAL SURGICAL PROCEDURE. FOLLOWING THE INCIDENT, THE MANUFACTURER PROVIDED A TRACKING # AND PACKAGING FOR THE RETURN OF THE DEFECTIVE DEVICE.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC LEFT HEMICOLECTOMY, THE FIRST LOAD OF THE SURGICAL STAPLER WORKED AS EXPECTED, BUT THE SECOND LOAD DID NOT WORK PROPERLY. IT FIRED AND CUT ONLY HALFWAY THEN GOT JAMMED. A THIRD LOAD WAS USED TO COMPLETE THE ORIGINAL SURGICAL PROCEDURE. FOLLOWING THE INCIDENT, THE MANUFACTURER PROVIDED A TRACKING # AND PACKAGING FOR THE RETURN OF THE DEFECTIVE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607847 PROXIMATE STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC TCR75 U4075G

    Patients

    Seq Age Sex Outcome Treatment
    1 17520 DA