BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUDI SUCTION, 70 - 1PK

    MDR report key: 16449080 · Received February 27, 2023

    Report

    Report Number
    3005172759-2023-00010
    Event Type
    Malfunction
    Date Received
    February 27, 2023
    Date of Event
    February 2, 2023
    Report Date
    April 6, 2023
    Manufacturer
    ACCLARENT, INC.
    Product Code
    PGW
    UDI-DI
    10705031245884
    PMA / PMN Number
    K180948
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO.: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, GENDER, WEIGHT, RACE, AND ETHNICITY WERE NOT PROVIDED. 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. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION AND TESTING. HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE AS INDICATED AS ¿OTHER¿ IN THIS SECTION AS THE REASON FOR NON-EVALUATION. IF THE DEVICE RETURNS, A DEVICE INVESTIGATION WILL BE PERFORMED. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT 2112087 PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. 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. 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. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO.: (B)(6). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THE INVESTIGATIONAL FINDING OF THE RETURNED DEVICE. [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, THE TRUDI NAVIGATION SYSTEM WAS SHOWING INACCURACIES DURING THE PROCEDURE. THE 70° TRUDI NAV SUCTION DEVICE (TDNS070Z / 2112087) WAS USED AND THE INACCURACY WAS REPORTED TO BE 3MM TO 5MM OFF ANTERIORLY. THE ICON ON THE TRUDI NAV WAS GREEN WHEN THE INACCURACY ISSUE WAS NOTED. THERE WAS NO ERROR MESSAGE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT OR PATIENT INJURY. ON 24-FEB-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PROCEDURE WAS A PRIMARY HYBRID FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS); THERE WERE NO NON-ACCLARENT DEVICES USED. THE 70° TRUDI NAV SUCTION DEVICE HAD BEEN REPROCESSED APPROXIMATELY 15 TIMES VIA THE AUTOMATED METHOD. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. THE INVESTIGATION FINDING IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: A NON-STERILE 70° TRUDI NAV SUCTION DEVICE WAS RECEIVED CONTAINED IN A DECONTAMINATION POUCH. VISUAL INSPECTION WAS PERFORMED. NO APPEARANCE OF DAMAGE WAS OBSERVED. THE ELECTRICAL FUNCTIONALITY WAS TESTED, AND THE DEVICE WAS CONFIRMED TO BE WITHIN SPECIFICATIONS FOR ALL THE CONNECTIVITY AND ISOLATION VALUES. THE UNIT WAS THEN CONNECTED INTO THE MAGNETIC CALIBRATION SYSTEM (MAGCS) FOR CALIBRATION CHECK AND IT PASSED THE TEST. BASED ON THE RESULTS OBTAINED, THE REPORTED ISSUE IN THE COMPLAINT WAS NOT CONFIRMED. THE TOOL WAS FOUND TO BE FUNCTIONAL. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT 2112087 PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. AS PART OF ACCLARENT¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. BASED ON THE MANUFACTURING DOCUMENTATION REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE / PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. 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. UPDATED SECTIONS: B.4, G.3, G.6. H.2, H.3, H.6, AND H.10. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO.: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THAT THE PRODUCT WAS RECEIVED IN THE PRODUCT ANALYSIS LAB ON 16-MAR-2023. THE RETURNED PRODUCT IS PENDING EVALUATION. A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED ONCE THE PRODUCT INVESTIGATION HAS BEEN COMPLETED. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, THE TRUDI NAVIGATION SYSTEM WAS SHOWING INACCURACIES DURING THE PROCEDURE. THE 70° TRUDI NAV SUCTION DEVICE (TDNS070Z / 2112087) WAS USED AND THE INACCURACY WAS REPORTED TO BE 3MM TO 5MM OFF ANTERIORLY. THE ICON ON THE TRUDI NAV WAS GREEN WHEN THE INACCURACY ISSUE WAS NOTED. THERE WAS NO ERROR MESSAGE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT OR PATIENT INJURY. ON (B)(6) 2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PROCEDURE WAS A PRIMARY HYBRID FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS); THERE WERE NO NON-ACCLARENT DEVICES USED. THE 70° TRUDI NAV SUCTION DEVICE HAD BEEN REPROCESSED APPROXIMATELY 15 TIMES VIA THE AUTOMATED METHOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560797 TRUDI SUCTION, 70 - 1PK EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT PGW ACCLARENT, INC. TDNS070Z 2112087 10705031245884

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown