BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUDI SUCTION, 70 - 1PK

    MDR report key: 18427698 · Received January 2, 2024

    Report

    Report Number
    3005172759-2024-00003
    Event Type
    Malfunction
    Date Received
    January 2, 2024
    Date of Event
    December 14, 2023
    Report Date
    February 6, 2024
    Manufacturer
    ACCLARENT, INC.
    Product Code
    PGW
    UDI-DI
    10705031245884
    PMA / PMN Number
    K180948
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 D.4: THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. 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 E.1: THE NAME, PHONE AND EMAIL ADDRESS OF THE INITIAL REPORTER ARE NOT AVAILABLE / REPORTED. SECTION H.4: THE DEVICE MANUFACTURE DATE IS NOT KNOWN AS THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. 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. THIS IS ONE OF 3 PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE: 3005172759-2024-00001 AND 3005172759-2024-00002.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. THE LOT NUMBER IS NOT KNOWN; THEREFORE, A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED. WITH THE INFORMATION AVAILABLE AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS, THE REPORTED CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED TO IDENTIFY STATISTICAL SIGNALS FOR CONSIDERATION OF FURTHER CORRECTION ACTION. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 0

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PRIMARY HYBRID FUNCTIONAL ENDOSCOPIC SINUS SURGERY PROCEDURE ON (B)(6) 2023, ACCURACY WAS OFF BY ABOUT 5-6MM. THE REPORTER STATED THAT THE INACCURACY OCCURRED ON THREE TRUDI NAVIGATION SUCTION DEVICES. ONE OF THESE THREE DEVICES ALSO HAD AN ¿ERROR CODE¿.THE DEVICES WITH THE ALLEGED PRODUCT MALFUNCTION WERE A TRUDI SUCTION, 0 - 1PK (TDNS000Z, 2207120032), TRUDI SUCTION, 0 - 1PK (TDNS000Z, LOT UNKNOWN) AND A TRUDI SUCTION, 70 - 1PK (TDNS070Z, LOT UNKNOWN). ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PHYSICIAN PERFORMED THE REGISTRATION. THE CUSTOMER CONFIRMED ACCURACY WAS PERFORMED BY USING THE REGISTRATION PROBE AFTER REGISTRATION PROCESS WAS COMPLETED. THE CUSTOMER CONFIRMED ACCURACY KNOWN LANDMARKS IN ENDOSCOPIC VISUALIZATION INSIDE THE NASAL CAVITY. THE INACCURACY WAS DETERMINED WHEN CONFIRMING ACCURACY ON KNOWN ANATOMY LANDMARKS, UNICANTE, MAX WALL. THE EVENT OCCURRED AT THE START OF THE CASE. THE INACCURACY WAS NOTICED BY USING THE REGISTRATION PROBE WITH INSTRUMENTATION. THEY PLUGGED IN THE DEVICES AFTER REGISTRATION. WHEN THE ACCURACY ISSUE WAS OBSERVED, THE ICON ON THE TRUDI NAV SYSTEM WAS GREEN. CT SCAN WAS PERFORMED VIA AXIAL VIEW. THERE WERE NO NOTICEABLE DEFECTS TO THE CT SCANNED IMAGE. STERILIZATION METHOD WAS USED AS PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO ERROR MESSAGE ON THE TRUDI NAVIGATION MONITOR FOR THE DEVICE. THE DEVICES WERE REPROCESSED 10 TIMES. THE PHYSICIAN WAS FRUSTRATED AND DECIDED TO CONTINUE THE PROCEDURE WITH THE ISSUE PERSISTING. THE CALLER IS REQUESTING DOCUMENTATION ONLY. THERE WAS NO DEATH OR SERIOUS INJURY THAT OCCURRED DUE TO THE USE OF THE PRODUCTS. THERE WAS NO REPORT OF PATIENT REQUIRING MEDICAL INTERVENTION AS A RESULT THE ALLEGED PRODUCT ISSUE. A SPINPLUS NAVIGATION BALLOON SINUPLASTY SYSTEM (RSP0616MFSN / LOT# UNKNOWN) WAS REPOTED AS HAVING A LOSS OF SIGNAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1410076 TRUDI SUCTION, 70 - 1PK EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT PGW ACCLARENT, INC. 10705031245884

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown RELIEVA SPINPLUS BALLOON SINUPLASTY SYSTEM.| TRUDI SUCTION, 0 - 1PK.| TRUDI SUCTION, 0 - 1PK.