BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUREFORM

    MDR report key: 16603598 · Received March 23, 2023

    Report

    Report Number
    2955842-2023-11499
    Event Type
    Malfunction
    Date Received
    March 23, 2023
    Date of Event
    February 28, 2023
    Report Date
    February 28, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    UDI-DI
    10886874117580
    PMA / PMN Number
    K183224
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ABNORMALITY IDENTIFIED. THE CUSTOMER CONFIRMED THAT THE MOVEMENT OF THE INSTRUMENT WAS SLIGHTLY SLOW. THERE WAS NO REPORT OF FRAGMENTS FALLING INSIDE THE PATIENT.

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE SUREFORM 45 STAPLER INSTRUMENT MOVED WITH UNINTUITIVE MOTION, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS CONTACTED FOR TROUBLESHOOTING ASSISTANCE. THE TSE ADVISED THE CUSTOMER TO RESEAT THE STERILE ADAPTER (SA). THE ISSUE WAS RESOLVED AFTER RESEATING THE S/A. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY, AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED. THE SUREFORM 45 STAPLER INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST ENGINEERING EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE SUREFORM 45 STAPLER INSTRUMENT MOVED WITH UNINTUITIVE MOTION (E.G. THE INSTRUMENT UNEXPECTEDLY JERKED/JUMPED/SWUNG/BOWED, MOVED IN AN UNEXPECTED/UNINTENDED/UNKNOWN WAY). UNINTUITIVE MOTION COULD LEAD TO SUBSEQUENT TISSUE DAMAGE. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE CUSTOMER CALLED IN TO REPORT THAT THE SUREFORM 45 STAPLER INSTRUMENT MOVED WITH UNINTUITIVE MOTION. AN ISI TECHNICAL SUPPORT ENGINEER (TSE) ADVISED THE CUSTOMER TO RESEAT THE STERILE ADAPTER (SA). THE ISSUE WAS RESOLVED AFTER RESEATING THE SA. THE TSE ALSO EXPLAINED ABOUT THE "SELECT RELOAD COLOR ON CONSOLE TOUCHPAD. COLOR WANT DETECTED" MESSAGE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORT OF PATIENT INJURY. 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
    1597884 SUREFORM SUREFORM 45 GDW INTUITIVE SURGICAL, INC 480445-04 T91220328 0055 10886874117580

    Patients

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