BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    CLARIFIX

    MDR report key: 23399782 · Received October 28, 2025

    Report

    Report Number
    3015967359-2025-99445
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Report Date
    April 24, 2026
    Manufacturer
    ENTELLUS MEDICAL, INC.
    Product Code
    GEH
    UDI-DI
    00850002250404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. REPORTED EVENTS: 15 EVENTS WERE REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS: 15 DEVICES HAD INVESTIGATION TYPES THAT HAVE NOT YET BEEN DETERMINED. EVALUATION FINDINGS (RESULTS/COMPONENTS): 15 DEVICES: RESULTS PENDING COMPLETION OF INVESTIGATION / PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE. PRODUCT DISPOSITION: 15 DEVICES: PRODUCT DISPOSITION IS NOT YET DETERMINED. ADDITIONAL INFORMATION: 15 DEVICES WERE LABELED FOR SINGLE-USE. 15 DEVICES WERE NOT REPROCESSED OR REUSED.

    Additional Manufacturer Narrative · 0

    THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. MFR REPORT # 3015967359-2025-99445. SUPPLEMENTAL RATIONALE CORRECTED DATA: B5, H1, H6, H11. 15 EVENTS WERE PREVIOUSLY REPORTED DURING THE REPORTING QUARTER; HOWEVER, 1 EVENT WAS REPORTED IN ERROR. 14 PREVIOUSLY REPORTED EVENTS ARE INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS. 3 DEVICES WERE NOT AVAILABLE FOR EVALUATION. 4 DEVICES WERE RECEIVED. 7 DEVICES HAD INVESTIGATION TYPES THAT HAVE NOT YET BEEN DETERMINED. EVALUATION FINDINGS (RESULTS/COMPONENTS). 3 DEVICES: NO FINDINGS AVAILABLE / PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE 4 DEVICES: MANUFACTURING PROCESS PROBLEM IDENTIFIED / MEMBRANE, ADHESIVE 7 DEVICES: RESULTS PENDING COMPLETION OF INVESTIGATION / PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE. PRODUCT DISPOSITION. 2 DEVICES: PRODUCT NOT RECEIVED. 4 DEVICES: SCRAPPED BY STRYKER. 1 DEVICE: SCRAPPED BY CUSTOMER. 7 DEVICES: PRODUCT DISPOSITION IS NOT YET DETERMINED.

    Description of Event or Problem · 0

    THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30, 2025. THIS REPORT SUMMARIZES 15 EVENTS FOR THE FAILURE: FREE OR UNRESTRICTED FLOW. 1 EVENT HAD PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT. 13 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT. 1 EVENT HAD CODE NOT FOUND!

    Description of Event or Problem · 0

    THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN (B)(6)- (B)(6) 2025. THIS REPORT SUMMARIZES 14 EVENTS FOR THE FAILURE: FREE OR UNRESTRICTED FLOW. 13 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT. 1 EVENT HAD A CANCELLED/ABORTED SURGICAL PROCEDURE AND TEMPORARY IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2307184 CLARIFIX UNIT, CRYOSURGICAL, ACCESSORIES GEH ENTELLUS MEDICAL, INC. 00850002250404

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown