BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUREFORM

    MDR report key: 16763171 · Received April 18, 2023

    Report

    Report Number
    2955842-2023-12029
    Event Type
    Malfunction
    Date Received
    April 18, 2023
    Date of Event
    December 21, 2022
    Report Date
    March 20, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874117597
    PMA / PMN Number
    K190999
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING AN ENGAGEMENT ISSUE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE CURVED-TIP SUREFORM STAPLER 45 WAS TESTED ON AN IN-HOUSE SYSTEM AND FAILED TO ENGAGE TWICE DUE TO THE ROLL HARD-STOP CHECK FAILING IN EACH ATTEMPT. THE CURVED-TIP SUREFORM STAPLER 45 MAIN TUBE WAS MANUALLY ROTATED AND INCREASED FRICTION COULD BE FELT. LOG REVIEW CONFIRMS THE CURVED-TIP SUREFORM STAPLER 45 HAD MULTIPLE ROLL HARD-STOP ENGAGEMENT FAILURES IN THE FIELD. THE BUSHING BINDS AGAINST THE MAIN TUBE DURING ROTATION, WHICH CAN LEAD TO ENGAGEMENT FAILURES ON THE ROLL AXIS. ROOT CAUSE OF THE BINDING BUSHING IS SUPPLIER MANUFACTURING. ON THE THIRD IN-HOUSE INSTALL, THE CURVED-TIP SUREFORM STAPLER 45 SUCCESSFULLY ENGAGED BUT NON-INTUITIVE MOTION WAS OBSERVED. THE GRIPS WERE MOVING IN THE OPPOSITE DIRECTION OF THE COMMANDED MOVEMENTS. THE ROLL MOTION WAS NOT SMOOTH AND WOULD NOT ROLL IN SOME INSTANCES. THIS NON-INTUITIVE MOTION CAN OCCUR WHEN A CURVED-TIP SUREFORM STAPLER 45 WITH HIGH ROLL FRICTION SUCCESSFULLY ENGAGES WITH THE SYSTEM DESPITE THE INCREASED FRICTION, WHICH LEADS TO THE ROLL AXIS OFFSET BEING CALCULATED IN A DIFFERENT POSITION THAN INTENDED. THE NON-INTUITIVE MOTION IS ALSO RELATED TO THE BINDING BUSHING. ADDITIONALLY, LOGS SHOW AN UNKNOWN FAILURE MODE INITIALIZATION FAILURE UPON THE ONLY SUCCESSFUL INSTRUMENT ENGAGEMENT DURING THE PROCEDURE. THE I-BEAM ASSEMBLY WAS INSPECTED AND APPEARED TO BE INTACT AND FREE OF LODGED COMPONENTS. THE I-BEAM WAS MANUALLY EXTENDED AND RETRACTED WITHOUT ISSUE. THE INITIALIZATION FAILURE WAS NOT REPLICATED IN-HOUSE. THE COMPLAINT REGARDING CONFIRMED WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. THE PROBABLE ROOT CAUSE OF ROLL HARD-STOP ENGAGEMENT FAILURES ON THE SUREFORM STAPLER 45 IS ATTRIBUTED TO ROLL AXIS FRICTION. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE SUREFORM STAPLER 45 INSTRUMENT MOVED WITH NON-INTUITIVE MOTION (E.G. THE INSTRUMENT UNEXPECTEDLY JERKED/JUMPED/SWUNG/BOWED, MOVED IN AN UNEXPECTED/UNINTENDED/UNKNOWN WAY). NON-INTUITIVE 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

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE CURVED-TIP SUREFORM STAPLER 45 INSTRUMENT FAILED TO ENGAGE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1093050 SUREFORM SUREFORM 45 CURVED-TIP NAY INTUITIVE SURGICAL, INC 480545-04 L10220627 10886874117597

    Patients

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