BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUREFORM

    MDR report key: 21881203 · Received April 22, 2025

    Report

    Report Number
    2955842-2025-14773
    Event Type
    Malfunction
    Date Received
    April 22, 2025
    Date of Event
    March 4, 2025
    Report Date
    March 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
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE SUREFORM 60 STAPLER INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A DRIVETRAIN FRICTION FAILURE BASED ON LOG REVIEW. UPON INSPECTION, THE I-BEAM WAS MANUALLY DRIVEN OUT AND WAS FOUND WITH LODGED STAPLES IN THE I-BEAM CANAL, LIKELY CAUSING THE HIGH DRIVETRAIN FRICTION FAILURES DURING INITIALIZATION. THE INSTRUMENT WAS FOUND TO HAVE 1(ONE) CLAMPING FAILURES WITHIN A SINGLE INSTALL BASED ON LOG REVIEW. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. DURING THE FAILURE ANALYSIS INSPECTION INTERNAL AND EXTERNAL THERE WAS NO ISSUE OBSERVED, THOUGH THE INSTRUMENT FAILED TO INITIALIZE WHEN INSERTED IN THE SYSTEM DISPLAYING AN ERROR MESSAGE" INSTRUMENT FAILURE DO NOT REUSE" IN MULTIPLE ATTEMPTS. ACCORDING MSC & DSP LOGS THE INSTRUMENT WAS FOUND TO HAVE 1 (ONE) UNCLAMPING FAILURE. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. UUNCLAMP FAILURE LOG REVIEW DETAILS: PROCEDURE TYPE: RADICAL CYSTECTOMY W/ ILEAL CONDUIT # OF UNCLAMP FAILURES = 1 RELOAD COLOR INSTALLED DURING FAILURE = SF BLUE 60 INSTALL NUMBER(S) OF INSTRUMENT DURING UNCLAMP FAILURE = 2ND # OF FIRINGS BY INST PRIOR TO UNCLAMP FAILURE = 1 UNCLAMP FAILURE COMPLETION PCT. = 99% CLAMP HISTORY OF INST. IN PROCEDURE WITH UNCLAMP FAILURE = 2 OF 2.

    Additional Manufacturer Narrative · 0

    THE SUREFORM 60 STAPLER INSTRUMENT HAS BEEN EVALUATED BY AN INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS ENGINEER (FAE). THE INITIAL FINDINGS WERE PARTIALLY CONFIRMED. THE INSTRUMENT PROCEDURE LOGS WERE REVIEWED AND CONFIRMED THE INSTRUMENT EXPERIENCED AN UNCLAMPING DRIVETRAIN FAILURE ON THE LAST INSTALL. THIS FAILURE RESULTS IN THE FORCE EXPIRATION OF THE STAPLER, WHICH PREVENTS FURTHER USE. IT IS LIKELY THE REASON THE INSTRUMENT WAS RETURNED. LOG REVIEW SHOWS NO HIGH DRIVETRAIN FRICTION INITIALIZATION FAILURES. ADDITIONALLY, AS FURTHER CLARIFICATION, NO SLEEVE DAMAGE WAS FOUND. THE INSTRUMENT WAS RE-INSTALLED ON AN IN-HOUSE SYSTEM. THE STAPLER ENGAGED, INITIALIZED, CLAMPED, FIRED, AND UNCLAMPED WITHOUT ISSUE. IT APPEARS THE RADIO FREQUENCY IDENTIFIER-ID (RFID) EDITOR WAS USED IN-HOUSE TO UN-EXPIRE THE INSTRUMENT FOR TESTING. THE UNCLAMPING FAILURE WAS NOT REPLICATED THROUGH ADDITIONAL TESTING OF THE DEVICE, INDICATING THE FAILURE IS RELATED TO FACTORS OUTSIDE THE DEVICE. DRIVETRAIN FAILURES TO 99% COMPLETION HAVE PREVIOUSLY BEEN INVESTIGATED AND ARE A RESULT OF A FAULTY UNIVERSAL SURGICAL MANIPULATOR (USM).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SUREFORM 60 STAPLER INSTRUMENT WAS A DISCREPANT RMA. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR PATIENT INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1338217 SUREFORM STAPLER 60 NAY INTUITIVE SURGICAL, INC 480460-09 K15231109 0708 10886874115647

    Patients

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