BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUCTION MCEN766 SINUS TUBE 3MM

    MDR report key: 14723560 · Received June 16, 2022

    Report

    Report Number
    3003249645-2022-00030
    Event Type
    Malfunction
    Date Received
    June 16, 2022
    Date of Event
    May 25, 2022
    Report Date
    July 15, 2022
    Manufacturer
    INTEGRA MICROFRANCE S.A.S.
    Product Code
    JZF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    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

    THE SINUS TUBE SUCTION (MCEN766) WAS RETURNED FOR EVALUATION: THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES RELATED TO THE REPORTED FAILURE WERE OBSERVED. ROOT CAUSE: EVALUATION OF THE SINUS TUBE SUCTION FOUND THAT THE DEVICE WAS BROKEN AT THE LASER WELDING BETWEEN THE HANDLE AND THE TUBE. THE TUBE ITSELF WAS NOT RETURNED FOR EVALUATION. NO MANUFACTURING DEFECT WAS FOUND, THE LASER WELDING WAS COMPLIANT. FAILURE ANALYSIS: AS THE TUBE IS A FRAGILE PART, THIS ISSUE IS LIKELY DUE TO AN IMPROPER HANDLING OF THE DEVICE DURING THE STORAGE OR THE REPROCESSING. NO FURTHER INVESTIGATION REQUIRED BASED ON THE ACCEPTABILITY OF RISK AND NO ADVERSE TRENDS IDENTIFIED. THIS WILL BE MONITORED AND TRENDED GOING FORWARD.

    Description of Event or Problem · 0

    A FACILITY REPORTED THAT DURING A MEATOTOMY, THE SURGEON USED THE SINUS TUBE SUCTION (MCEN766) ON CARTILAGE AND THE DEVICE FAILED, WHICH CONDUCTED TO DELAY THE SURGERY. THE DEVICE WAS IN CONTACT WITH THE PATIENT; HOWEVER, NO PATIENT INJURY OCCURRED AND DELAY IN SURGERY TIME IS UNKNOWN.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1310495 SUCTION MCEN766 SINUS TUBE 3MM PFM11 JZF INTEGRA MICROFRANCE S.A.S. 6246247

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown