BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 20351772 · Received October 2, 2024

    Report

    Report Number
    2955842-2024-19994
    Event Type
    Injury
    Date Received
    October 2, 2024
    Date of Event
    March 4, 2024
    Report Date
    September 4, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K140553
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE INFORMATION PROVIDED BY ARTICLE AUTHOR, GREEN RELOADS WERE USED FOR TRANSECTING THE BRONCHI, AND WHITE RELOADS WERE USED FOR VESSELS. THE AUTHOR DID NOT HAVE OTHER DETAILS OF THE MISFIRE ISSUES, BUT CONFIRMED THAT THE PROCEDURES THAT HAD MISFIRE ISSUES WERE PERFORMED IN 2023. IT WAS PROVIDED THAT NO PRODUCTS ARE AVAILABLE FOR RETURN. NO PATIENT DEMOGRAPHIC DATA WAS AVAILABLE EITHER.

    Additional Manufacturer Narrative · 0

    THERE IS INSUFFICIENT INFORMATION ON THE PROCEDURE DATES AND THUS A SYSTEM LOG WAS NOT AVAILABLE TO BE PERFORMED. THERE IS ALSO INSUFFICIENT INFORMATION TO DETERMINE THE SPECIFIC STAPLER INSTRUMENT THAT OCCURRED THE DEVICE MISFIRES, THEREFORE, THE PRODUCT IS REPORTED AS A GENERAL ENDOWRIST STAPLER INSTRUMENT. DUE TO THE LACK OF SPECIFIC INFORMATION ON THE EXACT DEMOGRAPHICS OF THE PATIENTS, THE MEDIAN AGE AND THE GENDER REPRESENTING THE MAJORITY OF THE PATIENT POPULATION HAVE BEEN USED. CITATION: OGIHARA, A., OMATA, M., SHIDEI, H. ET AL. INTRAOPERATIVE ROBOTIC SURGICAL SYSTEM-RELATED PROBLEMS IN ROBOT-ASSISTED THORACOSCOPIC SURGERY. GEN THORAC CARDIOVASC SURG 72, 593¿598 (2024). HTTPS://DOI.ORG/10.1007/S11748-024-02013-1. .

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    A REVIEW OF A CLINICAL ARTICLE THAT DISCUSSED THE INTRAOPERATIVE ISSUES ASSOCIATED WITH ROBOTIC SURGICAL DEVICES FOUND THE FOLLOWING INCIDENTS. IT WAS MENTIONED THAT OF THE 544 PATIENTS WITH LUNG MALIGNANCIES AND/OR MEDIASTINAL TUMORS UNDERWENT ROBOTIC-ASSISTED THORACIC SURGERIES, THERE WERE FIFTEEN DEVICE OR SYSTEM RELATED ISSUES. OF THE MENTIONED ISSUES, THERE WERE FIVE ROBOTIC STAPLER RELATED PROBLEMS WHERE THREE CASES INVOLVED FAILURE TO TRANSECT THE BRONCHI AND TWO CASES INVOLVED FAILURE TO TRANSECT THE PULMONARY ARTERY. ONE OF THE PULMONARY ARTERY MISFIRES WAS REPORTED WITH SUDDEN BLADE STOPPAGE DURING TRANSECTION OF THE PULMONARY ARTERY WHICH REQUIRED ADDITIONAL TRANSECTION WITH A THIRD PARTY LINEAR MECHANICAL STAPLER BY THE PATIENT-SIDE DOCTOR. IT WAS REPORTED THAT NO BLEEDING OCCURRED DURING THE PULMONARY ARTERY TRANSECTION. NONE OF THE PATIENTS WHO EXPERIENCED THESE PROBLEMS REQUIRED EMERGENT CONVERSION TO THORACOTOMY, AND THERE WAS NO 30-DAY OR 90-DAY MORTALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1916693 ENDOWRIST STAPLER 45 NAY INTUITIVE SURGICAL, INC 470298 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES