BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 17261751 · Received July 5, 2023

    Report

    Report Number
    2955842-2023-16810
    Event Type
    Malfunction
    Date Received
    July 5, 2023
    Date of Event
    June 1, 2023
    Report Date
    June 6, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    PMA / PMN Number
    K152421
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC.(ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: WHEN THE RELOAD WAS ATTACHED TO THE STAPLER BEFORE USING INSIDE THE PATIENT¿S ANATOMY, THE STAPLE FELL OUT FROM THE RELOAD. THERE WAS NO FRAGMENT FALLING INTO THE PATIENT¿S ANATOMY. THE PROCEDURE WAS COMPLETED ROBOTICALLY. A REVIEW OF THE PROVIDED IMAGE SHOWS A GREEN STAPLER 30 RELOAD WHICH HAS ONE STAPLE NOT SECURED WITHIN ITS RESPECTIVE PUSHER POCKET. THE STAPLE IS SHOWN OUTSIDE OF THE RELOAD AND ONE LEG IS BENT INWARDS. THE DISLODGED STAPLE WAS FROM THE ROW SECOND MOST DISTAL TO THE RELOAD, ON THE RIGHT SIDE. THE RELOAD HAS NOT BEEN FIRED, SO THE SHUTTLE COULD NOT HAVE INTERACTED WITH THAT ROW OF PUSHERS PRIOR TO INITIATING FIRING. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE GREEN STAPLER 30 RELOAD WAS ANALYZED AND REPORTED FAILURE WAS CONFIRMED. UPON VISUAL INSPECTION, THE RELOAD WAS FOUND TO BE NOT USED AND NOT FIRED. THE RELOAD WAS RETURNED WITH A DISLODGED UNFORMED STAPLE FROM ONE OF THE PUSHERS. NO OBVIOUS DAMAGE WAS OBSERVED. THE COMPLAINT REGARDING PROTRUDING STAPLE WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT, AN INVESTIGATION IS IN PROGRESS. INTUITIVE SURGICAL, INC. (ISI) REQUESTED THE RETURN OF THE DEVICE FOR FURTHER EVALUATION, HOWEVER IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, ONE STAPLE OF THE STAPLER 30 GREEN RELOAD PROTRUDED AND FELL ON THE FLOOR. THERE WAS NO PATIENT INVOLVEMENT. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459686 ENDOWRIST STAPLER 30 RELOAD GREEN GDW INTUITIVE SURGICAL, INC 48630G-04 M90220403

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DA VINCI INSTRUMENTS AND ACCESSORIES