BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMINIS SURGICAL SYSTEM

    MDR report key: 13646967 · Received March 2, 2022

    Report

    Report Number
    3014155960-2022-00001
    Event Type
    Malfunction
    Date Received
    March 2, 2022
    Date of Event
    January 13, 2022
    Report Date
    March 2, 2022
    Manufacturer
    MEMIC INNOVATIVE SURGERY LTD.
    Product Code
    QNM
    UDI-DI
    17290018151096
    PMA / PMN Number
    DEN190022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING ACTIONS WERE TAKEN TO INVESTIGATE THE EVENT: EXAMINED THE SYSTEM/SOFTWARE LOG FILES AND INTERVIEWED THE CLINICAL TEAM. EXAMINED THE INSTRUMENT (ARM). EXAMINED AVAILABLE PICTURES TAKEN DURING THE PROCEDURE. THE INVESTIGATION OF THE SYSTEM LOG FILES AND INTERVIEWING THE CLINICAL TEAM SHOWED THAT THE SURGEON TRIED TO OPERATE THE JOYSTICK TO OPERATE THE JOYSTICK TO RESUME FROM PAUSE STATE BUT WAS UNSUCCESSFUL. THE REASON THE SURGEON COULD NOT RELEASE THE ARM USING THE MRT IS THAT THE FORCE REQUIRED TO OPERATE THE MRT TOOL WAS MORE THAN EXPECTED BY THE USER (USER DIDN'T APPLY SUFFICIENT FORCE). BASED ON THE INVESTIGATION, THE FAILURE WAS A RANDOM COMPONENT FAILURE (SHOULDER SUBASSEMBLY) THAT WAS ONLY RECREATED WHEN A COMBINATION OF TWO SITUATIONS OCCURRED: A COMBINATION OF A CERTAIN TOLERANCE STACK-UP OF THE SHOULDER SUB-ASSEMBLY, AND AN ATYPICAL EXTERNAL FORCE APPLIED TO THE ARM (MISALIGNMENT BETWEEN THE ARM AND THE CANNULA). THIS MALFUNCTION WAS IDENTIFIED AND APPEARS IN THE FMEA FILE AS PART OF THE COMPANY'S RISK ANALYSIS PROCESS AND THE HAZARD WAS ASSESSED TO BE FUNCTIONAL ISSUE AND NOT SAFETY RELATED. THE POTENTIAL HARM WAS DEFINED AS PROLONGED PROCEDURE (IN ACTUAL SCENARIO IT WAS 5 ADDITIONAL MINUTES) AND THE SEVERITY OF THE RISK TO THE PATIENT WAS CATEGORIZED AS "LOW". BASED ON THE INVESTIGATION, INCLUDING A HEALTH HAZARD ASSESSMENT, IF SUCH MALFUNCTION WOULD RECUR, SEVERAL DESIGN MITIGATIONS AND CLINICAL ASPECTS ARE IN PLACE THAT WOULD PREVENT FROM ANY POTENTIAL INJURY TO THE PATIENT: BY USING THE EMERGENCY BUTTON (EMO), THE SYSTEM IMMEDIATELY STOPS, SO THE ARMS CANNOT MOVE INSIDE THE PATIENT UNINTENTIONALLY AND ELECTROSURGERY (IF ANY) IS DISABLED. IN ADDITION, THE END EFFECTOR (TIP) OF THE ARM IS NOT SHARP AND RELATIVELY BLUNT AND REMOVAL OF THE ARMS VIA THE CANNULA CAN BE PERFORMED IN A CONTROLLED MANNER, UNDER VISION. THEREFORE, THE CHANCE OF INJURY IS VERY LOW. IN ADDITION, DUE TO THE ARM'S DESIGN, IT IS POSSIBLE TO REMOVE THE ARM THROUGH THE CANNULA EVEN IF IT IS NOT STRAIGHT, SINCE THE ARM IS PLIABLE AND WILL STRAIGHTEN DURING ITS EXTRACTION THROUGH THE CANNULA. MOREOVER, REMOVAL OF THE ARM IS PERFORMED UNDER VISION THROUGH THE CANNULA. THE SURGEON IS CAPABLE OF MOVING THE OTHER JOINTS (EXCEPT THE SHOULDER JOINT THAT WAS NOT RESPONDING). EVEN IF THE ARM JOINT IS FLEXED, THE SURGEON IS ABLE TO SAFELY REMOVE IT BY ORIENTING THE ARM IN SUCH A WAY TO AVOID ANY IMPACT OR INJURY TO THE PATIENT. THE DELAY IN THE PROCEDURE, DUE TO THE MANUAL REMOVAL, IS ASSESSED TO BE MINIMAL (APPROXIMATELY 5-10 MINUTES). HENCE, IT IS ASSESSED THAT WHILE FROM THE FUNCTIONALITY PERSPECTIVE, IF SUCH MALFUNCTION WERE TO RECUR, THE ARM'S MALFUNCTION MIGHT LEAD TO MINOR PROCEDURE PROLONGATION (ABOUT 5-10 MINUTES) AND INCONVENIENCE OF THE SURGEON, HOWEVER PATIENT SAFETY IS NOT COMPROMISED. ACCORDING TO THE INVESTIGATION, THE ROOT CAUSE IS A COMBINATION OF A MECHANICAL FAILURE IN STACK-UP OF TOLERANCES IN PARALLEL TO EXCESSIVE EXTERNAL LOAD, SUCH AS THE LOAD CAUSED BY A MECHANICAL INTERFERENCE OF CANNULA. THE ARM'S DESIGN AND MANUFACTURING PROCESSES SHOULD BE UPDATED TO SUSTAIN HIGHER LOADS THAT MAY BE EXPERIENCED. IN ADDITION, THE MRT SHOULD BE EVALUATED TO PROVIDE A MORE CONVENIENT USER INTERFACE. THIS REPORT WAS SUBMITTED IN DELAY DUE TO TECHNICAL DIFFICULTIES WITH THE ACTIVATION OF THE ESG ACCOUNT. MEMIC HAS TRIED TO APPROACH ESG SEVERAL TIMES DURING THIS TIME PERIOD AND MADE ALL EFFORTS IN ORDER TO ESTABLISH THE ACCOUNT ON TIME. FIRST ESG TEST SUBMISSION WAS PERFORMED ON (B)(6) 2022 AND WAS REJECTED. NO NOTIFICATION WAS RECEIVED; THEREFORE, AFTER APPROACHING ESG HELP WITH NO SUCCESS, ADDITIONAL TEST SUBMISSION WAS PERFORMED ON FEB 17TH. APPARENTLY, THE TEST ENVIRONMENT WAS NOT ESTABLISHED CORRECTLY BY CDRH/ESG NOT INCLUDING MFR NUMBER AND THIS SUBMISSION FAILED AS WELL. THE TEST ENVIRONMENT WAS CORRECTED TO ENABLE COMPLETE SUBMISSION ON (B)(6) 2022. THIRD TEST SUBMISSION WAS THEN PERFORMED. THIS SUBMISSION WAS SUCCESSFUL, AND THE PRODUCTION ACCOUNT BECAME AVAILABLE ON (B)(6) 2022. ONLY THEN MEMIC WAS ABLE TO SUBMIT THIS MDR.

    Description of Event or Problem · 0

    THE EVENT WAS A MALFUNCTION AND NOT SAFETY RELATED. DURING THE PROCEDURE, ONE OF THE JOINTS (SHOULDER) OF ONE OF THE ROBOTIC ARMS COULD NOT BE STRAIGHTENED. FOLLOWING A FEW ATTEMPTS, STRAIGHTENING USING THE MANUAL RELEASE TOOL (MRT) WAS ATTEMPTED BUT THE JOINT DID NOT RESPOND. THE SURGEON THEN DECIDED TO FOLLOW AN ALTERNATIVE ROUTE OF DISCONNECTING THE ARMS FROM THE ROBOTIC CONTROL UNIT (RCU) AND SUCCESSFULLY REMOVED THE ARM SAFELY THROUGH THE RIGID METALLIC CANNULA. BY DESIGN, THE ARM CAN BE REMOVED THROUGH THE CANNULA EVEN IF IT IS NOT STRAIGHT SINCE THE ARM IS PLIABLE AND WILL STRAIGHTEN DURING ITS EXTRACTION THROUGH THE CANNULA. THIS MALFUNCTION IS ASSESSED TO BE A FUNCTIONAL ISSUE AND NOT SAFETY RELATED. NO HARM OR INJURY TO THE PATIENT WAS REPORTED. A HEALTH HAZARD ANALYSIS WAS PERFORMED WITH RESPONSIBLE CLINICIANS. IT WAS ASSESSED THAT IF THE MALFUNCTION WERE TO RECUR IT IS NOT LIKELY TO RESULT IN DEATH OR SERIOUS INJURY. THE MDR IS REPORTED IN ABUNDANCE OF CAUTION AS THE "BY DESIGN" MITIGATION FOR THE PRODUCT PROBLEM LISTED IN THE RISK ANALYSIS FILE DID NOT PERFORM IN A SATISFACTORY WAY, AS EXPECTED BY THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787307 HOMINIS SURGICAL SYSTEM MOUNTABLE ELECTROMECHANICAL SURGICAL SYSTEM FOR TRANSLUMINAL APPROACHES QNM MEMIC INNOVATIVE SURGERY LTD. HOMINIS ARM 17290018151096

    Patients

    Seq Age Sex Outcome Treatment
    1 Female