BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULA

    MDR report key: 16749800 · Received April 17, 2023

    Report

    Report Number
    3007697975-2023-00003
    Event Type
    Malfunction
    Date Received
    April 17, 2023
    Date of Event
    April 2, 2018
    Report Date
    September 15, 2022
    Manufacturer
    EUROMI SA
    Product Code
    GEA
    PMA / PMN Number
    878.4800
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEFORMATION IS VISIBLE ON THE CANNULA. STAINLESS STEEL SHOWS NO SIGNS OF CORROSION OR SHOCK. THE LINEARITY OF THE CANNULA IS NOT A PROBLEM. FATIGUE IS A PROCESS (SUCCESSION OF MECHANISMS) THAT, UNDER THE ACTION OF TIME-VARYING STRESSES OR DEFORMATIONS, MODIFIES THE LOCAL PROPERTIES OF A MATERIAL. THESE CAN LEAD TO THE FORMATION OF CRACKS AND POSSIBLY THE BREAKING OF THE STRUCTURE. THE FATIGUE IS CHARACTERIZED IN PARTICULAR BY A RANGE OF STRESS VARIATION WHICH CAN BE WELL BELOW THE ELASTIC LIMIT OF THE MATERIAL. THE MAIN STAGES OF FATIGUE FAILURE OF AN ASSEMBLY ARE CRACK INITIATION (IF DEFECTS ARE NOT ALREADY PRESENT IN THE MATERIAL), CRACK PROPAGATION AND FINAL FAILURE. FATIGUE DAMAGE OCCURS PRIMARILY IN AREAS WITH THE HIGHEST ALTERNATING STRESSES, THAT IS TO SAY IN AREAS OF STRESS CONCENTRATION (HOLES, NOTCHES, JUNCTION BETWEEN THE BASE AND THE TUBE). THE WELD BETWEEN THE BASE AND THE TUBE IS A STRESS CONCENTRATION ZONE. HOWEVER, THE CANNULA WAS MARKETED IN NOVEMBER 2017. THE RUPTURE OCCURS 5 MONTHS AFTER THE MARKETING OF THE CANNULA. THE MANUAL FOR MONITORING THE USE OF THE CANNULA HAS NOT BEEN TRANSMITTED TO EUROMI. IT IS THEREFORE NOT POSSIBLE TO KNOW PRECISELY THE NUMBER OF USES THAT THE CANNULA HAS UNDERGONE. THIS BREAK CAN ALSO BE RELATED TO A WELDING DEFECT. EUROMI CANNULAS ARE SUBJECT TO AN INSTALLATION QUALIFICATION (MANUAL ONLY STEP) AND VALIDATION. IN ADDITION, THE COMPLIANCE OF THE WELD IS ROUTINELY CONTROLLED DURING CANNULA PRODUCTION (1 CANNULA CONTROLLED FOR 50 CANNULAS PRODUCED). HOWEVER, THE WELDING STEP IS A MANUAL STEP, EACH CANNULA IS WELDED INDIVIDUALLY AND A NON-COMPLIANCE RELATED TO THE WELD CAN NOT BE RULED OUT. WELDING DEFECTS CAN BE RELATED TO TWO ELEMENTS: - A TEMPERATURE DEFECT DURING BRAZING (WELDING OF THE BASE AND THE TUBE); - A LACK OF QUANTITY OF SOLDER FOR SOLDERING CASE N ° 1: TEMPERATURE FAULT STAINLESS STEEL 316 AND 316L ARE AUSTENITIC STEELS, STRUCTURALLY ORGANIZED UNDER AN IRON-CHROMIUM-NICKEL SYSTEM (BETWEEN 16 AND 18% OF CHROMIUM AND BETWEEN 10 AND 14% OF NICKEL). INOX 316 AND 316L PHASE CHANGE FOR THE TEMPERATURE OF 1500 ° C: PHASE A IF THE FORMATION TEMPERATURE OF THE INOX AND WELDING IS LESS THAN 1500 ° C; PHASE (A + L) IF THE TEMPERATURE IS 1500 ° C; PHASE L IF THE TEMPERATURE IS HIGHER THAN 1500 ° C. THE MELTING TEMPERATURE OF THE FILLER METAL IS BETWEEN 650 ° C AND 710 ° C. HOWEVER, THE FLAME TEMPERATURE OF ACETYLENE MIXED WITH OXYGEN IS ABOUT 3100 ° C. EVEN IF TEMPERATURE VARIATIONS OCCUR, THE TEMPERATURE ALWAYS REMAINS ABOVE 1500 ° C. NO PHASE CHANGE OF THE METAL TAKES PLACE. THIS HYPOTHESIS IS NOT RETAINED. CASE 2: INSUFFICIENT QUANTITY OF THE FILLER METAL THE SOLDERING STEP IS A MANUAL STEP. THE OPERATOR WHO CARRIES OUT THIS STEP IS TRAINED AND EVALUATED (VERIFICATION OF THE EFFECTIVENESS OF THE TRAINING). THE METHOD IS FORMALIZED IN A PROCEDURE. THE MATERIAL IS CONTROLLED VIA ITS MATERIAL CERTIFICATE BEFORE EACH USE. IN ADDITION, EACH WELD IS INSPECTED VISUALLY (NO BEAD, UNCAPPED CANNULA, FILLER METAL PRESENT). HOWEVER, A SMALLER AMOUNT OF SOLDER THAN IS NECESSARY TO ENSURE OPTIMAL CANNULA RESISTANCE (WELD) CAN NOT BE SEEN VISUALLY (ONLY BY TRACTION BENCH - DESTRUCTIVE TEST). HUMAN ERROR CAN OCCUR DESPITE THE PRECAUTIONS THAT ARE TAKEN. LOT 16EEHI305 CONSISTS OF 10 CANNULAS. IT IS NOT POSSIBLE TO TEST THE CANNULAS OF THIS LOT IN TRACTION TO MAKE SURE THAT THIS IS AN ISOLATED ERROR BECAUSE THE CANNULAS HAVE ALL BEEN MARKETED. ON THESE 10 CANNULAS, ANOTHER CASE OF MATERIOVIGILANCE WAS NOTED: A CANNULA BROKE DURING AN INTERVENTION. HOWEVER, THE ZONE OF THE BREAK IS HIGHER THAN THE BASE. THE ASSUMPTIONS THAT HAVE BEEN RETAINED FOR THIS CASE ARE: - FOLDING OF THE CANNULA: TO ACCESS DIFFICULT AREAS OR TO AVOID USING SEVERAL DIFFERENT CANNULAS, THE SURGEON WAS ABLE TO BEND THE CANNULA AT THE BASE; - SHOCK IN THE AREA WHERE THE BREAK OCCURRED. THE CANNULA BROKE DUE TO AN ISOLATED HUMAN ERROR, WHICH IS ATTRIBUTABLE TO EUROMI. TO ALLEVIATE THIS PROBLEM, WHICH IS NOT VISIBLE TO THE NAKED EYE, EUROMI WISHES TO AUTOMATE ITS WELDING IN 2019 IN ORDER TO ENSURE GREATER REPRODUCIBILITY OF ITS WELDING (MODIFICATION MANAGEMENT EN7- J-009- CANNULAS NLF-16042018: INSTALLATION OF ORBITAL WELDING FOR CANNULAS). THIS SUBSTANTIAL CHANGE HAS ALREADY BEEN SUBMITTED TO OUR NOTIFIED BODY. THE DELAY IN MDR SUBMISSION IS DUE TO EMPLOYEE TURNOVER IN THE QUALITY DEPARTMENT. UPDATE 15/09/2022 : THIS MODIFICATION DID NOT SUCCEED DUE TO THE NON FEASIBILITY

    Description of Event or Problem · 0

    A LIPOSUCTION SYSTEM CANNULA BEGAN TO VIBRATE DURING A LIPOSUCTION PROCEDURE. THE SURGEON REMOVED THE CANNULA FROM THE PATIENT. THE CANNULA BENT AND BROKE.NO CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2279304 CANNULA CANULE 3G INOX 3*350 GEA EUROMI SA ASPIRATION CANULA 3G 16EEHI305

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention