BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUREFORM

    MDR report key: 21609493 · Received March 14, 2025

    Report

    Report Number
    2955842-2025-08172
    Event Type
    Malfunction
    Date Received
    March 14, 2025
    Date of Event
    February 17, 2025
    Report Date
    February 17, 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
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE SUREFORM 60 STAPLER, AND THE SUREFORM 60 WHITE RELOAD INVOLVED WITH THIS COMPLAINT; HOWEVER, FAILURE ANALYSIS HAS NOT COMPLETED THEIR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING INFORMATION: THESE ARE TWO SEPARATE ISSUES AND TWO SEPARATE COMPLAINTS SAME SURGEON, SAME TYPE OF INSTRUMENT. FIRST ISSUE WAS FAILURE TO UNCLAMP (HE WAS NOT PRESENT FOR THIS CASE) WHICH IS THE REPORTABLE ONE AND THE OTHER WAS DIFFICULT TO INSTALL DUE TO MEASUREMENT OF RELOAD. THEY ARE NOT THE SAME STAPLER. THE STAPLER FOR THE GENERAL COMPLAINT DIFFICULT TO INSTALL WILL NOT BE RETURNED AS IT WAS USED IT FOR OTHER PROCEDURES. CSR EMAILED THE TWO INCIDENTS BECAUSE WHEN HE ARRIVED ON SITE, THEY HAD ALREADY COMPLETED THE 1ST CASE WHICH IS WHERE IT FAILED TO UNCLAMP. BOTH CASES WERE COMPLETED AND HAVE HAD NO OTHER ISSUES SINCE THEN. PATIENT IDENTIFIER 1236952 WAS CREATED TO CAPTURE THE SECOND PROCEDURE. ISI DID RECEIVE THE SUREFORM 60 STAPLER TO PERFORM FAILURE ANALYSIS (FA). FA WAS NOT ABLE TO CONFIRM NOR REPRODUCE THE CUSTOMER REPORTED COMPLAINT. VISUAL INSPECTION DISPLAYED NO SIGNS OF PHYSICAL DAMAGE. THE CHANNEL SPRANG BACK OPEN WHEN IN THE UNCLAMPED STATE. THE WHITE RETURNED RELOAD ATTACHED TO AND REMOVED FROM THE INSTRUMENT WITHOUT ANY ISSUES. AN IN-HOUSE WHITE RELOAD ATTACHED TO AND REMOVED FROM THE INSTRUMENT WITHOUT ANY ISSUES. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. THE INSTRUMENT WAS FULLY FUNCTIONAL. THERE WAS NO PROBLEM DETECTED. ISSUES RELATED TO INSTRUMENT ERRORS OR COMPLICATIONS USING THE INSTRUMENT REPORTED BY THE USER WITH NO UNDERLYING PRODUCT ISSUE MAY BE RELATED TO CUSTOMER-INDUCED PROBLEMS, INCLUDING MISUSE OF THE PRODUCT AND RECOGNITION ISSUES. ISI DID RECEIVE THE SUREFORM 60 WHITE RELOAD TO PERFORM FA. FA WAS NOT ABLE TO CONFIRM NOR REPRODUCE THE CUSTOMER REPORTED COMPLAINT. RELOAD WAS RETURNED USED AND FIRED. IT WAS RETURNED WITH SUREFORM 60 STAPLER INSTRUMENT. VISUAL INSPECTION DISPLAYED NO SIGNS OF PHYSICAL DAMAGE TO THE CARTRIDGE, KNIFE, PUSHERS, OR COVER. THE RELOAD ATTACHED TO AND REMOVED FROM THE RETURNED INSTRUMENT WITHOUT ANY ISSUES ON MULTIPLE ATTEMPTS. NO PRODUCT ISSUE WAS IDENTIFIED. ISSUES RELATED TO INSTRUMENT ERRORS OR COMPLICATIONS USING THE INSTRUMENT REPORTED BY THE USER WITH NO UNDERLYING PRODUCT ISSUE MAY BE RELATED TO CUSTOMER-INDUCED PROBLEMS, INCLUDING MISUSE OF THE PRODUCT AND RECOGNITION ISSUES. A DEVICE HISTORY RECORD (DHR) REVIEW FOR THE DEVICE(S) INVOLVED WITH THE REPORTED EVENT HAS BEEN COMPLETED. NO NON-CONFORMANCES WERE IDENTIFIED TO BE RELATED TO THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTROSTOMY SURGICAL PROCEDURE, THE SURGEON REPORTED UNUSUAL ACTIVITY FROM A SUREFORM 60 STAPLER. INITIALLY, THE STAPLER WORKED AS INTENDED AND FIRED TWO BLUE RELOADS. THEN THE STAPLER WAS RELOADED WITH A WHITE RELOAD. HOWEVER, AFTER INSTALLATION ON THE ARM WITH THE WHITE RELOAD, IT AUTOMATICALLY CALIBRATED AND SHOWED AS A GREEN RELOAD ON THE ARM INSTRUMENT STATUS BAR AND WOULD NOT ASK HER TO CONFIRM RELOAD COLOR. THE STAPLER WITH THE WHITE RELOAD WAS REMOVED AND REINSTALLED AND THE SURGEON WAS THEN REQUIRED TO SELECT RELOAD AT SURGEON CONSOLE. SURGEON SELECTED WHITE AND PROCEEDED TO TAKE CONTROL AND CLAMP. SURGEON INITIATED A FIRE AND WAS GIVEN TISSUE TOO THICK TO CONTINUE AFTER A FEW MILLIMETERS THEN DECIDED TO UPSIZE TO A BLUE RELOAD AND NOTICED THAT THE STAPLER DID NOT SEEM TO OPEN ALL THE WAY AND DECIDED TO OPEN A NEW STAPLER. THE CASE WAS COMPLETED WITH THE NEW STAPLER AND NO UNEXPECTED CLINICAL OUTCOME. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: ON THIS CASE THE STAPLER WAS INSTALLED WITHOUT ISSUE HOWEVER THE RELOAD COLOR WAS NOT BEING READ CORRECTLY. ONCE THEY INSERTED A NEW RELOAD AND INSERTED INTO THE PATIENT THE SURGEON NOTICED THE STAPLER WAS NOT OPENING. THEY REMOVED THE STAPLER AND REPLACED IT WITH A BACK-UP TO COMPLETE THE PROCEDURE WITHOUT INJURY OR IMPACT TO THE PATIENT. COULD NOT CONFIRM IF THE ISSUE OCCURRED WHILE ON TISSUE HOWEVER IT WAS DEFINITELY IN THE PATIENT. THE STAPLER WILL BE RETURNED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1112271 SUREFORM STAPLER 60 NAY INTUITIVE SURGICAL, INC 480460-09 L88230914 0035 10886874115647

    Patients

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