BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUREFORM

    MDR report key: 23101514 · Received September 19, 2025

    Report

    Report Number
    2955842-2025-38458
    Event Type
    Malfunction
    Date Received
    September 19, 2025
    Date of Event
    August 26, 2025
    Report Date
    August 26, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874115647
    PMA / PMN Number
    K173721
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE SUREFORM 60 STAPLER INSTRUMENT WAS ANALYZED, AND THE FINDINGS DID NOT REPLICATE OR CONFIRM THE CUSTOMER REPORTED EVENT. A VISUAL INSPECTION DISPLAYED NO SIGNS OF PHYSICAL DAMAGE. THE CHANNEL SPRANG BACK OPEN WHEN IN THE UNCLAMPED STATE. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS, AND IT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. THE STAPLER WAS TESTED IN-HOUSE, AND THE INSTRUMENT INITIALIZED, CLAMPED, FIRED, AND UNCLAMPED WITHOUT ANY ISSUES. THE INSTRUMENT FIRED SUCCESSFULLY TWICE USING A WHITE 60 RELOAD. THE CUTLINE APPEARED SMOOTH AND CONSISTENT, WITH NO JAGGED EDGES OR TEARING OBSERVED. ALL STAPLES WERE DEPLOYED AND CORRECTLY FORMED INTO THE PROPER B-SHAPE. A REVIEW OF SYSTEM LOGS WAS UNABLE TO VERIFY ANY FAILURES. THE INSTRUMENT WAS FULLY FUNCTIONAL. THE INSTRUMENT WAS VISUALLY INSPECTED AND EVALUATED FOR ITS MECHANICAL AND/OR ELECTRICAL CHARACTERISTICS. THE FAILURE ANALYSIS INVESTIGATIONS AND IN-HOUSE TESTING OF THE RETURNED INSTRUMENT REVEALED NO ISSUES RELATED TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE CUSTOMER HAD NO CONTROL OVER THE STAPLER IN UNIVERSAL SURGICAL MANIPULATOR (USM4). A SUREFORM 60 STAPLER INSTRUMENT WAS INSTALLED IN USM4 AND THE SURGEON HAD NO CONTROL. PRIOR TO CALLING, THE CUSTOMER REPLACED THE INSTRUMENT WITH NO FURTHER ISSUES. THE CUSTOMER POWER CYCLED SYSTEM PRIOR TO CALLING AND NO LOGS WERE AVAILABLE. THE TECHNICAL SUPPORT ENGINEER (TSE) RECOMMENDED THE CUSTOMER RETURN ORIGINAL SUREFORM 60 INSTRUMENTS. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE STAPLER IN ARM 4 WAS NOT ABLE TO BE CONTROLLED. THE MOVEMENTS WERE NOT APPROPRIATE TO WHAT THE SURGEON WAS DOING. THE SURGEON WAS ABLE TO REMOVE THE INSTRUMENT AND INSTALL A BACKUP TO COMPLETE THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT. THERE WAS NO BLEEDING NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1766424 SUREFORM STAPLER 60 NAY INTUITIVE SURGICAL, INC 480460-12 K12250612 0040 10886874115647

    Patients

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