BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERT CEV625-1 FENESTRATED 350MM

    MDR report key: 24709123 · Received March 30, 2026

    Report

    Report Number
    3003249645-2026-00008
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    February 16, 2026
    Report Date
    March 26, 2026
    Manufacturer
    INTEGRA MICROFRANCE S.A.S.
    Product Code
    GEI
    UDI-DI
    10381780094494
    PMA / PMN Number
    K993655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSERT CEV625-1 FENESTRATED 350MM (CEV625-1) WAS RETURNED FOR AN EVALUATION. THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED BECAUSE NO DATA WAS AVAILABLE CORRESPONDING TO THE YEAR OF MANUFACTURE, 2004. FAILURE ANALYSIS: THE INVESTIGATION FINDINGS NOTED THAT THE COMPLAINT CONCERNS THE ASSEMBLY OF THREE PARTS: THE CEV10395R HANDLE, BATCH 09-03, MANUFACTURED IN 2003 ((B)(4)); THE CEV649-5B TUBE, BATCH 091102 ((B)(4)), MANUFACTURED IN 2009; AND THE CEV625-1 INSERT, BATCH 11-04 ((B)(4)), MANUFACTURED IN 2004. THESE THREE INSTRUMENTS ARE OLD. THE TUBE WAS REPAIRED BY AN EXTERNAL SERVICE PROVIDER. DURING THIS REPAIR, THE METAL SURFACE WAS MATTED, WHEREAS OUR INTERNAL PROCESS NORMALLY INVOLVES BRUSHING. TO PREVENT ANY DAMAGE TO THE MARKINGS DURING THE REPAIR, THE SERVICE PROVIDER COVERED THEM; THIS PRACTICE DOES NOT MEET INTEGRA STANDARDS. UPON ITS RETURN, THE TUBE UNDERWENT OUR ELECTRICAL TESTING AND PASSED THE TEST. THE HANDLE SHOWS NO DAMAGE; IT WAS REPAIRED BY AN EXTERNAL PROVIDER BECAUSE IT BEARS A NON-IMF MARKING. THE INSERT EXHIBITED SOME TWISTING, BUT THIS IS UNRELATED TO THE INITIAL REPORTED ISSUE AND DOES NOT AFFECT THE CURRENT CLAIM. ROOT CAUSE ANALYSIS: DESPITE THEIR AGE, THE INSTRUMENTS SHOWED NO DAMAGE RELATED TO THE USER'S REPORTED PROBLEM. INSPECTIONS REVEALED NO ANOMALIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED INCIDENT. SINCE THE INSTRUMENTS WERE NOT DIRECTLY IMPLICATED, THE BURN WAS CAUSED BY USER ERROR: THE INSTRUMENT WAS POWERED ON DURING HANDLING, AND THE METAL PART OF THE TUBE CAME INTO CONTACT WITH THE PATIENT'S ABDOMEN, RESULTING IN THE OBSERVED BURN. THE INSERT EXHIBITS SLIGHT TWISTING: THIS DEFORMATION IS CONSISTENT WITH THE MECHANICAL STRESSES THAT CAN OCCUR DURING CLEANING CYCLES OR WHEN STORED IN CONTACT WITH OTHER INSTRUMENTS. NO CORRELATION WAS FOUND BETWEEN THIS TWISTING AND THE INITIAL PROBLEM REPORTED IN THE COMPLAINT. INTEGRA MICROFRANCE (IMF) RECOMMENDS REPAIRS WITHIN ITS FACTORY AND CANNOT GUARANTEE THE SERVICES PROVIDED BY AN EXTERNAL SERVICE PROVIDER.

    Description of Event or Problem · 0

    THIS IS 3 OF 3 REPORTS AND IS RELATED TO MFG NUMBER, 3003249645-2026-00006 AND 3003249645-2026-00007. A FACILITY REPORTED THAT A BURN OCCURRED ON A PATIENT DURING A LAPAROSCOPIC REPAIR OF ABDOMINAL WALL HERNIA ASSOCIATED WITH AN UMBILICAL HERNIA, WITH MESH PLACEMENT, INVOLVING THE INSERT CEV625-1 FENESTRATED 350MM (CEV625-1). THE PATIENT SUSTAINED A SUPERFICIAL BURN, WHICH HAS RESULTED IN A SMALL BURN SCAR. THE HEALTHCARE FACILITY PROVIDED LOCAL CARE AND MONITORING OF THE PATIENT, AND THE MEDICAL DEVICE WAS QUARANTINED. THERE WAS NO REPORT OF AN INCREASE IN SURGICAL TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769800 INSERT CEV625-1 FENESTRATED 350MM MICROFRANCE INSTRUMENTS GEI INTEGRA MICROFRANCE S.A.S. 11-04 10381780094494

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown