BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUREFORM

    MDR report key: 15613102 · Received October 16, 2022

    Report

    Report Number
    2955842-2022-14652
    Event Type
    Malfunction
    Date Received
    October 16, 2022
    Date of Event
    August 2, 2022
    Report Date
    September 16, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    UDI-DI
    10886874117597
    PMA / PMN Number
    K190999
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL ANALYSIS WAS PERFORMED ON THE SUREFORM 45 CURVED-TIP STAPLER BY AN ADVANCED FAILURE ANALYSIS ENGINEER. HOUSING WAS REMOVED, AND I-BEAM WAS ATTEMPTED TO BE MANUALLY DRIVEN OUT BUT COULD NOT BE FULLY DRIVEN OUT. I-BEAM FORWARD PROGRESS STOPPED AFTER A FEW MILLIMETERS. THE I-BEAM SLEEVE WAS OBSERVED TO BE DAMAGED. INSTRUMENT WAS DISASSEMBLED TO FIND THE ORANGE I-BEAM SLEEVE DAMAGED NEAR THE DISTAL CLEVIS. BASED ON VISUAL INSPECTION, FIRING FAILURES AND SUBSEQUENT INITIALIZATION FAILURES APPEARS TO BE A RESULT OF A DAMAGED I-BEAM SLEEVE. THE CAUSE OF DAMAGE TO I-BEAM SLEEVE IS UNKNOWN AT THIS POINT, HOWEVER, IT'S POSSIBLE THAT THE I-BEAM SLEEVE IS CATCHING SOME INTERNAL COMPONENTS AT THE DISTAL END DURING I-BEAM EXTENSION/RETRACTION, CAUSING INCREASED FRICTION THAT LEADS TO EVENTUAL DAMAGE OF THE SLEEVE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE SUREFORM 45 CURVED-TIP STAPLER INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS CONFIRMED THE REPORTED COMPLAINT OF RECOGNITION FAILURE ISSUE. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF INITIALIZATION FAILURE TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE HI DRIVETRAIN FRICTION FAILURES BASED ON LOG REVIEW AND DURING IN-HOUSE TESTING. LOGS SHOWED 5 HI DRIVETRAIN FRICTION FAILURES DURING INITIALIZATION. THE STAPLER WAS PLACED ON THE IN-HOUSE SYSTEM AND FAILED INITIALIZATION ON 2 OUT OF 3 ATTEMPTS. ADDITIONAL OBSERVATIONS, WHICH WERE NOT REPORTED BY THE SITE, WERE THAT THE INSTRUMENT WAS FOUND TO HAVE A JAMMED I-BEAM. THE I-BEAM WAS MANUALLY DRIVEN OUT FOR INSPECTION BUT FAILED TO COMPLETELY EXTEND PAST THE 40 MARK ON THE STAPLER JAWS. NO LODGED STAPLES WERE OBSERVED IN THE I-BEAM WINDOW OR KNIFE TRACK. THIS INSTRUMENT WILL BE TRANSFERRED TO ADVANCED FAILURE ANALYSIS ENGINEER FOR FURTHER INSPECTION. THE INSTRUMENT WAS FOUND TO HAVE MULTIPLE ENGAGEMENT FAILURES BASED ON LOG REVIEW, BUT THE ISSUE WAS NOT REPLICATED DURING IN-HOUSE TESTING. LOGS SHOWED ERROR CODE 22020 WITH P3=537919482, INDICATING THE INSTALLED SUREFORM 45 FAILED TO ENGAGE ON UNIVERSAL SURGICAL MANIPULATOR (USM)2 (ROLL AXIS HARDSTOP CHECK FAILED). THE INSTRUMENT WAS PLACED ON THE IN-HOUSE SYSTEM AND PASSED ENGAGEMENT ON 3 OUT OF 3 ATTEMPTS. NO FRICTION WAS OBSERVED WHEN MANUALLY ROTATING THE INSTRUMENT SHAFT. THE ROOT CAUSE WAS NOT DETERMINED. THE INSTRUMENT WAS FOUND TO HAVE A FIRING FAILURE(S) BASED ON LOG REVIEW BUT WAS NOT REPLICATED DURING IN-HOUSE TESTING. THE INSTRUMENT WAS NOT FIRED DURING IN-HOUSE TESTING DUE TO THE JAMMED I-BEAM. THE ROOT CAUSE WAS NOT DETERMINED. PARTIAL FIRE (PF) LOGS WERE REVIEWED: NUMBER OF PF IN THE PROCEDURE=1; GREEN 45 RELOAD WAS INSTALLED; PARTIAL FIRE COMPLETION PERCENT= 47.4 PERCENT; FIRING NUMBER OF PF BY INSTRUMENT IN PROCEDURE = 5TH FIRE; OVERALL FIRING NUMBER = 5TH OVERALL FIRING; CLAMP HISTORY = 5 COMPLETE CLAMPS. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. A REVIEW OF THE DEVICE LOGS FOR THE SUREFORM 45 CURVED-TIP STAPLER (PART #: 480545-04, LOT/SERIAL #: (B)(4)) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER THIS REVIEW OF THE LOGS, THE SUREFORM 45 CURVED-TIP STAPLER WAS LAST USED ON (B)(6) 2022 VIA SYSTEM SERIAL # :(B)(4). THERE WERE 7 USES REMAINING AFTER THIS LAST USAGE. THIS LAST USAGE OF THE DEVICE, PER THE LOG REVIEW, MATCHES THE REPORTED EVENT DATE INDICATING THAT THE INSTRUMENT WAS NOT USED AFTER THE DATE OF THE REPORTED EVENT. A REVIEW OF THE PROCEDURE LOG SHOWED THE SITE PERFORMED THIS PULMONARY LOBECTOMY SURGICAL PROCEDURE ON (B)(6) 2022 VIA SYSTEM SERIAL #: (B)(4). BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: FAILURE ANALYSIS CONFIRMED THE IBEAM ASSEMBLY WAS JAMMED. MEDICAL INTERVENTION MAY BE REQUIRED IN THE EVENT THAT THE STAPLER FAILS TO UNCLAMP FROM TISSUE WHEN COMMANDED BY THE USER OR SYSTEM. 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, A CUSTOMER REPORTED THAT A RECOGNITION FAILURE OCCURRED ON SUREFORM 45 STAPLER INSTRUMENT. THE CUSTOMER REPLACED THE SUREFORM 45 INSTRUMENT WITH A BACKUP. THE PROCEDURE WAS CONTINUING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED TO USE WITH NO ISSUE. SUREFORM 45 CURVED-TIP STAPLER DID NOT FAIL TO UNCLAMP FROM THE TISSUE WHEN IT WAS COMMANDED BY THE SURGEON. INFORMATION REGARDING PATIENT DEMOGRAPHICS, RELEVANT TESTING, AND MEDICAL HISTORY WERE REQUESTED; HOWEVER, THE REPORTER WAS NOT ABLE TO PROVIDE THAT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2939519 SUREFORM SUREFORM 45 CURVED-TIP GDW INTUITIVE SURGICAL, INC 480545-04 T90220311 0066 10886874117597

    Patients

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