BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK_REUSABLE INSTRUMENTS

    MDR report key: 21528322 · Received March 5, 2025

    Report

    Report Number
    3005172759-2025-00021
    Event Type
    Malfunction
    Date Received
    March 5, 2025
    Date of Event
    February 12, 2025
    Report Date
    April 8, 2025
    Manufacturer
    ACCLARENT, INC.
    Product Code
    PGW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF#: (B)(4). UPDATED SECTIONS ON THIS MEDWATCH: B4, G3, G6, H2, H3, H6 AND H11. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. HOWEVER, IF THE PRODUCT OR PRODUCT ID NUMBERS ARE RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, GENDER, WEIGHT, RACE, AND ETHNICITY WERE NOT PROVIDED. SECTION D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. SECTION D.4: THE TRUDI DEVICE DOES NOT HAVE AN EXPIRATION DATE; IT IS NOT A SINGLE USE DEVICE. TRUDI¿ SUCTION INSTRUMENTS ARE SUPPLIED NON-STERILE AND MUST BE CLEANED AND STERILIZED PRIOR TO EACH USAGE. SECTION H3 - THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION AND TESTING. HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE. IF THE DEVICE RETURNS, A DEVICE INVESTIGATION WILL BE PERFORMED. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ACCLARENT, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ACCLARENT, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PRIMARY FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE IN THE OPERATING ROOM (OR), UPON INITIAL CONNECTION OF THE 0° DEGREE TRUDI¿ NAV SUCTION DEVICE ( TDNS000Z, 2212120027), THE TRUDI¿ NAVIGATION SYSTEM DISPLAYED A RED BAR UNDER THE DEVICE ICON. THE 0° DEGREE TRUDI¿ NAV SUCTION DEVICE WAS RECONNECTED TO A DIFFERENT INSTRUMENT ADAPTER OR DONGLE, WITHOUT RESOLUTION. THE 0° DEGREE TRUDI¿ NAV SUCTION DEVICE WAS CONNECTED TO A DIFFERENT TRUDI¿ NAV CABLE WITHOUT RESOLUTION. THE 0° DEGREE TRUDI¿ NAV SUCTION DEVICE WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE CONTINUED. IT WAS ALSO REPORTED THAT UPON INITIAL CONNECTION OF THE 70° DEGREE TRUDI¿ NAV SUCTION DEVICE, THE TRUDI¿ NAVIGATION SYSTEM DISPLAYED A RED BAR UNDER THE DEVICE ICON. THE 70° DEGREE TRUDI¿ NAV SUCTION DEVICE WAS RECONNECTED TO A DIFFERENT INSTRUMENT ADAPTER OR DONGLE, WITHOUT RESOLUTION. THE 70° DEGREE TRUDI¿ NAV SUCTION DEVICE WAS CONNECTED TO A DIFFERENT TRUDI¿ NAV CABLE WITHOUT RESOLUTION. THE 70° DEGREE TRUDI¿ NAV SUCTION DEVICE WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE CONTINUED. THERE WAS NO ALLEGATION THAT A DEATH OR SERIOUS INJURY OCCURRED DUE TO THE USE OF THE PRODUCT. THERE WAS NO REPORT OF THE PATIENT REQUIRING MEDICAL INTERVENTION. NO NON ACCLARENT DEVICES WERE USED. ADDITIONAL EVENT INFORMATION RECEIVED ON 14-FEB-2025 INDICATED THAT FOR THE 0° TRUDI NAV SUCTION DEVICE, THE DEVICE WAS REPROCESSED 19 TIMES. THERE WAS NO ERROR MESSAGE ON THE TRUDI NAV MONITOR FOR THE DEVICE. THEY PLUGGED IN THE DEVICE AFTER REGISTRATION. FOR THE 70° SUCTION DEVICE, THE DEVICE WAS REPROCESSED 8 TIMES. THERE WAS NO ERROR MESSAGE ON THE TRUDI NAV MONITOR FOR THE DEVICE. THEY PLUGGED IN THE DEVICE AFTER REGISTRATION. THE CUSTOMER CONFIRMED ACCURACY USING THE REGISTRATION TRUDI PROBE (PRODUCT, LOT UNKNOWN) AFTER REGISTRATION PROCESS WAS COMPLETED. THE CUSTOMER CONFIRM ACCURACY IN THE KNOWN LANDMARKS IN ENDOSCOPIC VISUALIZATION INSIDE THE NASAL CAVITY. INACCURACY WAS DETERMINED ANECDOTALLY. INACCURACY WAS FIRST NOTICED WHEN GOING TO THE FRONTAL SINUS, SUCTION AND PROBE SHOWED IN ORBIT. ACCURACY WAS VALIDATED USING THE REGISTRATION PROBE. 186 CT IMAGE SLICES WERE USED. THERE WERE NO NOTICEABLE DEFECTS TO THE CT SCANNED IMAGES. THE REGISTRATION WAS PERFORMED BY THE SURGEON, WHO HAS BEEN TRAINED AND HAS PERFORMED MANY REGISTRATIONS. ACCURACY WAS CONFIRMED LATERAL CANTHI, NASION AND NASAL SEPTUM. METAL INTERFERENCE WAS INTERMITTENT WHEN USING THE TRUDI SHAVER (PRODUCT,LOT NUMBER UNKNOWN). OTHER PATIENTS HAVE HAD INACCURACY AND THERE HAVE BEEN OTHER CASES OF SUCTIONS MALFUNCTIONING. ADDITIONAL EVENT INFORMATION RECEIVED ON 18-FEB-2025 NOTED THAT FOR THE TRUDI SUCTION DEVICE WHEN THE ACCURACY ISSUES WAS OBSERVED, THE BAR BELOW THE DEVICE ICON ON THE TRUDI SYSTEM MONITOR WAS ¿SOMETIMES GREEN SOMETIMES ORANGE¿. THE DEVICE WAS PLUGGED AFTER REGISTRATION. ACCORDING TO THE SURGEON, THE INACCURACY WAS NOT WITHIN 2MM. IT WAS ALSO NOTED THAT WHEN THE PROBE ACCURACY ISSUES WAS OBSERVED, THE BAR BELOW THE DEVICE ICON ON THE TRUDI SYSTEM MONITOR WAS GREEN. THE DEVICE WAS PLUGGED AFTER REGISTRATION. ACCORDING TO THE SURGEON, THE INACCURACY WAS NOT WITHIN 2MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436502 UNK_REUSABLE INSTRUMENTS EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT PGW ACCLARENT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown TRUDI NAVIGATION SYSTEM| TRUDI SUCTION, 0 - 1PK| TRUDI SUCTION, 70 - 1PK| UNKNOWN TRUDI SHAVER