BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDLINE INDUSTRIES, INC.

    MDR report key: 11603096 · Received April 1, 2021

    Report

    Report Number
    1417592-2021-00064
    Event Type
    Injury
    Date Received
    April 1, 2021
    Date of Event
    March 18, 2021
    Report Date
    April 1, 2021
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    LRO
    UDI-DI
    10193489472837
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING A SCHEDULED DAVINCI BILATERAL INGUINAL HERNIA REPAIR THAT WAS CONVERTED TO A LAPAROSCOPIC HERNIA REPAIR WHEN A PROBLEM WAS ENCOUNTERED DURING THE SECOND HALF OF THE PROCEDURE. THE FACILITY REPORTED THE FOLLOWING INCIDENT: THE CHARGE NURSE AND THE FACILITY ASSOCIATE WERE URGENTLY CALLED TO THE OPERATING ROOM. UPON ARRIVAL THE NURSE AND ANESTHESIOLOGIST WERE TRYING TO REPOSITION THE PATIENT ON THE REGULAR OPERATING ROOM TABLE. ACCORDING TO THE SCRUB TECHNICIAN AND THE SURGEON, THEY NOTICED THAT ONE OF THE DAVINCI ARMS ALARMED INDICATING THE INSTRUMENT HAS BEEN REMOVED. THE SAME STAFF NOTICED THAT THE ARM WAS OUTSIDE OF THE PATIENT'S ABDOMEN AND WAS MISSING A LOADED NEEDLE AT THE END OF IT. ATTENTION WAS QUICKLY DIRECTED TO THE PATIENT'S POSITION ON THE BED. THE PATIENT WAS FOUND SHIFTED OFF OF THE BED ABOUT 2 INCHES CAUSING THE DAVINCI ARM TO EXIT ONE OF THE ABDOMINAL INCISIONS. THE STERILE FIELD AND ROBOT ARMS WERE CONTAMINATED DURING REPOSITIONING SO NEW SUPPLIES WERE CALLED IN. THE SURGEON CONVERTED THE PROCEDURE FROM A ROBOTIC TO A LAPAROSCOPIC APPROACH. A NEEDLE WAS LEFT INSIDE OF THE PATIENT FROM THE LOSS OF THE INITIAL POSITIONING; HOWEVER THE NEEDLE WAS SUCCESSFULLY REMOVED AFTER THE PROCEDURE WAS RESTARTED LAPAROSCOPICALLY. THE ACTUAL SAMPLE IS NOT AVAILABLE TO RETURN FOR EVALUATION. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING A SCHEDULED DAVINCI BILATERAL INGUINAL HERNIA REPAIR THAT WAS CONVERTED FROM A ROBOTIC TO A LAPAROSCOPIC HERNIA REPAIR WHEN THE PATIENT WAS FOUND SHIFTED OFF OF THE BED ABOUT 2 INCHES CAUSING THE DAVINCI ARM TO EXIT ONE OF THE ABDOMINAL INCISIONS AND THE STERILE FIELD WAS CONTAMINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499199 MEDLINE INDUSTRIES, INC. OR TURNOVER KIT LRO MEDLINE INDUSTRIES INC. DYKC1586 10193489472837

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention