BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 9929165 · Received April 6, 2020

    Report

    Report Number
    2955842-2020-10281
    Event Type
    Injury
    Date Received
    April 6, 2020
    Date of Event
    February 7, 2020
    Report Date
    March 11, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    PMA / PMN Number
    K140553
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED EVENT IS UNKNOWN. IF ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED. ISI COULD NOT REVIEW OR EVALUATE THE FOLLOWING; SYSTEM LOGS, PHOTO, VIDEO, OR ANY PRODUCT EVALUATION SINCE THERE IS NO ADDITIONAL INFORMATION PROVIDED REGARDING THE DA VINCI SURGICAL SYSTEM, HOSPITAL SITE NAME, OR PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON WAS FIRING A BLUE 45MM DA VINCI XI STAPLER, IT ONLY FIRED STAPLES HALF WAY AND STOPPED ON THE PARENCHYMA. A NEW STAPLER INSTRUMENT AND NEW GREEN 45MM RELOAD WAS USED SUCCESSFULLY. HOWEVER, AS PER THE MEDWATCH, IT IS UNKNOWN AT THIS TIME IF ANY MEDICAL INTERVENTION WAS RENDERED TO THE PATIENT, AT THIS TIME, THE ROOT CAUSE OF THE REPORTED ISSUE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    ON 11-MARCH-2020, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT MW5093127 WITH THE FOLLOWING INFORMATION: WHEN THE SURGEON WAS FIRING BLUE 45MM DA VINCI XI STAPLER, IT ONLY FIRED STAPLES HALF WAY AND STOPPED ON THE PARENCHYMA. A NEW STAPLER INSTRUMENT AND NEW GREEN 45MM RELOAD WAS USED SUCCESSFULLY. PER THE MEDWATCH, IT IS UNKNOWN AT THIS TIME IF ANY MEDICAL INTERVENTION WAS RENDERED TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE DA VINCI SURGICAL SYSTEM, HOSPITAL SITE NAME, OR PATIENT. AS A RESULT, INTUITIVE SURGICAL, INC. (ISI) COULD NOT PERFORM FOLLOW-UP INVESTIGATION TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393766 ENDOWRIST STAPLER 45 RELOAD BLUE GDW INTUITIVE SURGICAL, INC 48645B-04 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention