BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUCTION TUBE MCO770-3-0 120MM DIA 3.0MM

    MDR report key: 23286795 · Received October 15, 2025

    Report

    Report Number
    3003249645-2025-00043
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 15, 2025
    Report Date
    February 4, 2026
    Manufacturer
    INTEGRA MICROFRANCE S.A.S.
    Product Code
    JZF
    UDI-DI
    10381780109846
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: G3, G6, H2, H6: TYPE OF INVESTIGATION 2, INVESTIGATION CONCLUSIONS 1, AND H11. ADDITIONAL INFORMATION: INVESTIGATION UPDATE. ROOT CAUSE ANALYSIS: THE PRODUCT WAS RETURNED BY THE CUSTOMER, AND THE INVESTIGATION CONFIRMED THE REPORTED NON-CONFORMITY. THE SUCTION TUBE SHOWS A LOCALIZED FRACTURE IN THE WELDED AREA. EXAMINATION UNDER A BINOCULAR MICROSCOPE REVEALED A LOCALIZED REDUCTION IN METAL THICKNESS AT THE FRACTURE SITE, AS WELL AS THE PRESENCE OF MICRO-POROSITIES. ANALYSIS OF POTENTIAL CAUSES: BASED ON THE OBSERVATIONS, SEVERAL FACTORS MAY HAVE CONTRIBUTED TO THE DAMAGE OF THE TUBE. A LOCALIZED WEAKENING OF THE MATERIAL, POSSIBLY RELATED TO THE LASER WELDING PROCESS PARAMETERS USED DURING MANUFACTURING, CANNOT BE EXCLUDED. HOWEVER, THE OBSERVED MICRO-POROSITIES SUGGEST A LOCAL PERFORATION OF THE TUBE WITH MATERIAL REMAINING AROUND THE AFFECTED AREA. THIS FAILURE MODE IS NOT CONSISTENT WITH A MANUFACTURING PROCESS ERROR. INDEED, A PROCESS-RELATED DEFECT WOULD HAVE RESULTED IN MISSING MATERIAL OR A COMPLETE PERFORATION OF THE TUBE, AS WELL AS MELTING OF THE OPPOSITE TUBE WALL, WHICH WAS NOT OBSERVED. FURTHERMORE, IF ANY WEAKENING HAD OCCURRED DURING THE MANUFACTURING PROCESS, IT WOULD NOT HAVE CAUSED IMMEDIATE FRACTURE, BUT RATHER FAILURE AFTER SEVERAL USES. IT SHOULD ALSO BE NOTED THAT A 100% INSPECTION IS PERFORMED DURING THE FINAL INSPECTION. THE AFFECTED BATCH CONSISTS OF 10 INSTRUMENTS, AND NO OTHER NON-CONFORMITIES OR SIMILAR COMPLAINTS HAVE BEEN REPORTED FOR THIS BATCH TO DATE, INDICATING THAT THIS EVENT IS ISOLATED WITH NO KNOWN RECURRENCE. CONSEQUENTLY, A MANUFACTURING OR WELDING PROCESS ERROR IS EXCLUDED AT THIS STAGE OF THE ANALYSIS. MECHANICAL OR THERMAL STRESSES OCCURRING AFTER MANUFACTURING (HANDLING OR CONDITIONS OF USE) MAY ALSO HAVE CONTRIBUTED TO THE FRACTURE IN A LOCALLY SENSITIVE AREA. BASED ON THE OBSERVATIONS AND PRODUCT HISTORY, IT IS LIKELY THAT EXCESSIVE FORCE APPLIED DURING ASSEMBLY CAUSED MECHANICAL DAMAGE TO THE TUBE. DAMAGE OCCURRING DURING STERILIZATION CANNOT BE RULED OUT EITHER. ROOT CAUSE: BASED ON CURRENT OBSERVATIONS, THE MOST PROBABLE ROOT CAUSE IS MECHANICAL DAMAGE TO THE TUBE RELATED TO HANDLING DURING STERILIZATION, COMBINED WITH EXCESSIVE FORCE APPLIED DURING ASSEMBLY OR USE. ACTIONS IMPLEMENTED: AS A PREVENTIVE MEASURE, INFORMATION WAS PROVIDED TO THE CONCERNED OPERATOR TO REINFORCE AWARENESS OF WELDING PARAMETERS AND THEIR SUITABILITY FOR THE TYPE OF TUBE USED.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D9, G3, G6, H2, H3, H6, H11. THE SUCTION TUBE MCO770-3-0 120MM DIA 3.0MM (MCO770-3-0) WAS RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ABNORMALITIES RELATED TO THE REPORTED ISSUE WERE OBSERVED. FAILURE ANALYSIS: THE PRODUCT WAS RETURNED, AND THE ASSESSMENT CONFIRMED THE REPORTED PROBLEM. THE SUCTION TUBE HAS A BREAK AT THE WELD. EXAMINATION UNDER A BINOCULAR MICROSCOPE REVEALS A REDUCTION IN THE METAL THICKNESS AT THE BREAK, AS WELL AS THE PRESENCE OF SMALL HOLES. ROOT CAUSE ANALYSIS: DURING THE LASER WELDING PROCESS, IT IS LIKELY THAT THE PROGRAM USED WAS TOO POWERFUL FOR THIS TYPE OF TUBE, RESULTING IN LOCALIZED WEAKENING OF THE MATERIAL. ACTION TAKEN: THE OPERATOR INVOLVED HAS BEEN NOTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SUCTION TUBE MCO770-3-0 120MM DIA 3.0MM (MCO770-3-0) BROKE DURING VACUUMING. THE SALES REPRESENTATIVE STATED THAT BREAKAGE OCCURRED AT THE HANDLE JUNCTION, AND NO FRAGMENTS FELL INTO THE PATIENT; AN ALTERNATIVE PRODUCT WAS USED TO COMPLETE THE SURGERY. THERE WAS NO INJURY OR DEATH; HOWEVER, A 15-MINUTE SURGICAL PROLONGATION WAS REPORTED.

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2791950 SUCTION TUBE MCO770-3-0 120MM DIA 3.0MM PFM11 JZF INTEGRA MICROFRANCE S.A.S. 6942387 10381780109846

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown