BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI ENERGY

    MDR report key: 16519154 · Received March 9, 2023

    Report

    Report Number
    2955842-2023-11202
    Event Type
    Malfunction
    Date Received
    March 9, 2023
    Date of Event
    August 26, 2022
    Report Date
    February 15, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874117306
    PMA / PMN Number
    K191280
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE SYNCHROSEAL BY THE CUSTOMER NOTING THE JAWS OF THE INSTRUMENT COULD NO LONGER CLOSE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE SYNCHROSEAL INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A FAILED INTUITIVE MOTION IN THE GRIP CLOSING MOTION. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT¿S GRIP TIPS WERE NOT MOVING INTUITIVELY, I.E. THEY WERE NOT FOLLOWING THE MASTER TOOL MANIPULATOR (MTM) INPUT COMMANDS SMOOTHLY. THE INSTRUMENT GRIPS CAN OPEN BUT WOULD CLOSE ONLY HALFWAY. UPON VISUAL INSPECTION, THE JAW CERAMIC DOTS WERE PRESENT. A REVIEW OF LOGS SHOWED NO FAILURES. PER ADVANCED FAILURE ANALYSIS, THE INITIAL FAILURE ANALYSIS WAS CONFIRMED. THE JAWS OF THE INSTRUMENT WOULD NOT CLOSE ALL THE WAY. THIS WAS BOTH WITH THE GRIP RELEASE LEVER AND ON THE SYSTEM. THE INSTRUMENT'S HOUSING WAS REMOVED, AND IT WAS NOTICED THAT THE GRIP KEG WAS NOT RETURNING ALL THE WAY TO THE TOP, WHICH WOULD CLOSE THE JAWS FULLY. FURTHER INVESTIGATION FOUND THAT THE GRIP SLUG THAT HOLDS THE GRIP TORSION SPRING APPEARED TO BE OUT OF SYNC WITH THE GRIP SHAFT, MOST LIKELY DUE TO THE LOOSE SET SCREW OBSERVED THAT ATTACHES THE GRIP SHAFT AND SLUG. THIS CAN CAUSE AN ISSUE IF THE GRIP SHAFT IS ABLE TO SLIP WITH RESPECT TO THE SLUG. THE PROBABLE ROOT CAUSE FOR THE LOOSE SET SCREW IS TYPICALLY ATTRIBUTED TO MANUFACTURING. ADDITIONALLY, THE INSTRUMENT WAS TESTED TO OBSERVE IF THE INSTRUMENT COULD ATTEMPT TO SEAL. THE MTM WAS CLOSED AS FAR AS THEY COULD GO, AND THE GRIPS COULD NOT FULLY CLOSE. THE SEAL OPTION BECAME AVAILABLE ON THE SSC, AND THE PEDAL WAS PRESSED TO ATTEMPT TO SEAL. HOWEVER, IT APPEARS THE INSTRUMENT WAS UNABLE TO INITIATE A SEAL AS THE "ENSURE THE APPROPRIATE AMOUNT OF TISSUE IN JAWS. INCOMPLETE SEAL CYCLE." MESSAGE APPEARED. THE COMPLAINT REGARDING GRIP CLOSING FAILURE WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. FAILURE ANALYS FOUND ADDITIONAL OBSERVATION RELATED TO THE REPORTED ISSUE AND NOT REPORTED BY SITE: THE INSTRUMENT FAILED THE GRIP FORCE TEST, LIKELY DUE TO THE FAILED GRIP CLOSURE MOTION. FA PERFORMED GRIP FORCE TEST WITH THE SPECIFIED PARAMETERS AND INSTRUCTIONS: THE PASSING RANGE WAS BETWEEN 3.28 LBS AND 7.97 LBS FOR THE SYNCHROSEAL AND THE INSTRUMENT FAILED AT 0.11 LBS IN THE STRAIGHT ORIENTATION. THE PROBABLE ROOT CAUSE OF THE REPORTED INTUITIVE MOTION IN THE GRIP CLOSING MOTION CANNOT BE DETERMINED. BASED ON THE INFORMATION AVAILABLE AT THIS TIME, THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: FAILURE ANALYSIS CONFIRMED THE INSTRUMENT FAILED THE HARD GRIP FORCE FAILURE TEST. MEDICAL INTERVENTION MAY BE REQUIRED IN THE EVENT THAT THE SYNCHROSEAL 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 HEMICOLECTOMY SURGICAL PROCEDURE, THE JAWS OF THE SYNCHROSEAL 8MM INSTRUMENT COULD NO LONGER CLOSE, EITHER MANUALLY OR AUTOMATICALLY AFTER AROUND 30 MINUTES OF USE. THE PROCEDURE COMPLETED AS PLANNED. THERE WAS NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE INSTRUMENT WAS CHECKED PRIOR TO USE AND THERE WAS NO VISUAL DAMAGE. SEALING WAS THE SURGICAL TASK BEING PERFORMED AT THAT TIME. AFTER 30 MINUTES THE SURGEON COULD NOT SEAL THE TISSUE BECAUSE THE INSTRUMENT COULD NOT BE CLOSED. THE INSTRUMENT COULD BE REMOVED WITH OPEN JAWS THROUGH TROCAR. THE PROCEDURE WAS COMPLETED WITH A BACK-UP INSTRUMENT WITH NO PATIENT HARM. THE INSTRUMENT WAS WORKING DURING THE FIRST 30 MINUTES. NO ERRORS OCCURRED WHEN THE SYNCHROSEAL ISSUE HAPPENED, AND THE DISSECTION OF THE BOWEL WAS THE TARGET TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1790260 DA VINCI ENERGY SYNCHROSEAL NAY INTUITIVE SURGICAL, INC 480440-06 L90220418 0056 10886874117306

    Patients

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