BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANULE VITERBO 3*250 MM TUNGSTÈNE

    MDR report key: 16741260 · Received April 14, 2023

    Report

    Report Number
    3007697975-2023-00002
    Event Type
    Malfunction
    Date Received
    April 14, 2023
    Date of Event
    August 6, 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
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CANNULA HAS NO NICKS OR CRACKS IN THE HOLES OF THE CANNULAE. NO TRACE OF CORROSION IS VISIBLE ON THE CANNULA (BASE, NO SCREWS, HOLES AND TUBE). THE CANNULA HAS A SLIGHT LACK OF LINEARITY. THE BREAK AT THE BASE IS NOT CLEAR. STREAKS CAN BE OBSERVED ON THE CANNULA NETTING AND ON THE NETTING THREAD AT THE BROKEN ZONE. THE OBSERVED FRACTURE FACIES SUGGESTS A PROPAGATION OF A CRACK AND THEN A TEARING ZONE (WHICH MUST CORRESPOND TO THE FINAL RUPTURE). THE RUPTURE OF THE CANNULA IS THEREFORE LINKED TO CRACKING OF THE CANNULA. CRACK FORMATION IS RELATED TO SEVERE SHOCK OR CANNULA WEAR (MATERIAL FATIGUE). THE SHOCK HYPOTHESIS IS EXCLUDED BECAUSE THE CANNULA SHOWS NO OTHER SIGNS OF SHOCK (NON-DEFORMED WARHEAD, UNDEFORMED BASE AND NO SIGN OF DAMAGE TO THE CANNULA LINER IN THE RUPTURE ZONE). 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 SURFACE CONDITION OF THE CANNULA HAS NO DEFECT; - NO CORROSION IS TO BE DEPLORED. - THE MATERIAL USED IS INOX 316 L AT THE TUBE AND INOX 316 AT THE BASE. THE CANNULA IS COVERED WITH A MINIMUM THICKNESS OF 2 UM OF TUNGSTEN CARBIDE. THE THICKNESS OF THE TUBE MAY ALSO INFLUENCE THE RESISTANCE OF THE CANNULA. THE TUBE IS 0.43 MM THICK, WHICH IS IN ACCORDANCE WITH THE DESIGN SPECIFICATIONS OF THE LIPOSUCTION CANNULA DEVICE. - THE AMPLITUDE OF SOLICITATION IS MANAGED BY THE DOCTOR. HOWEVER, A LIPOSUCTION PROCEDURE IS NOT RECOMMENDED IN CASE OF OBESITY. THUS, THE AMPLITUDE OF STRESS REMAINS LIMITED. - FINALLY, BEYOND A CERTAIN NUMBER OF USES, THE CANNULA WILL BREAK UNDER STRESS (AND THEREFORE, DURING AN INTERVENTION). EUROMI LIMITS THE NUMBER OF USES OF A CANNULA TO 200 INTERVENTIONS. A DURATION OF 2 YEARS IS ALSO RECOMMENDED TO LIMIT THE OXIDATION OF THE CANNULA. THE CANNULA WAS SOLD ON MAY 10, 2016. THE CANNULA IS THEREFORE MORE THAN TWO YEARS OLD AND HAS BROKEN BEYOND THE PERIOD OF USE RECOMMENDED BY EUROMI. THE LAST HYPOTHESIS IS THE ONE THAT WAS RETAINED DURING OUR ANALYSIS. THE DELAY IN MDR SUBMISSION IS DUE TO EMPLOYEE TURNOVER IN THE QUALITY DEPARTMENT. WE HAVE RECEIVED A REQUEST FOR RENEWAL FROM (B)(6) AS OUR MEDWATCH SUBMITTED VIA ESG PORTAL HAS NOT BEEN RECEIVED BY THE FDA.

    Description of Event or Problem · 0

    AT THE BEGINNING OF A LIPOSUCTION PROCEDURE, WHEN THE CANNULA WAS INSERTED INTO THE PATIENT'S BODY, THE CANNULA BROKE AT THE BASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901211 CANULE VITERBO 3*250 MM TUNGSTÈNE LIPOSUCTION SYSTEM CANNULA, REUSABLE GEA EUROMI SA 16EGBC428

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other