BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUDI SUCTION, 0 - 1PK

    MDR report key: 14749934 · Received June 20, 2022

    Report

    Report Number
    3005172759-2022-00010
    Event Type
    Malfunction
    Date Received
    June 20, 2022
    Date of Event
    June 3, 2022
    Report Date
    July 28, 2022
    Manufacturer
    ACCLARENT, INC.
    Product Code
    PGW
    UDI-DI
    10705031245877
    PMA / PMN Number
    K180948
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(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. 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 (2112100) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. 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. 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 THE INVESTIGATIONAL FINDING OF THE RETURNED DEVICE. [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN IN-OFFICE PRIMARY HYBRID BALLOON SINUPLASTY (BSP) PROCEDURE, THE 0° TRUDI NAV SUCTION DEVICE (TDNS000Z / 2112100) WAS INACCURATE ON THE TRUDI SYSTEM (S/N: (B)(6)). THE SUCTION DEVICE WAS REPLACED AND THE ISSUE WAS RESOLVED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION ASSOCIATED WITH THE REPORTED INACCURACY ISSUE. ON 06-JUN-2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT WHEN THE ACCURACY ISSUE WAS OBSERVED, THE ICON ON THE TRUDI SYSTEM WAS GREEN. THERE WAS NO ERROR MESSAGE ON THE TRUDI NAVIGATION MONITOR FOR THE DEVICE. THE SUCTION DEVICE WAS PLUGGED IN AFTER REGISTRATION. THE PATIENT TRACKER WAS NOT MOVED AND THE PATIENT TRACKER CABLE WAS NOT UNDER TENSION IN RELATION TO THIS EVENT. COMPUTED TOMOGRAPHY (CT) IMAGE WAS USED AS THE PRIMARY IMAGE. THE CT SCAN CONTAINED 460 SLICES. THE INACCURACY ISSUE WAS DETERMINED BY COMPARING TRUDI PROBE. THERE WAS NO FERROMAGNETIC MATERIAL PLACED WITHIN THE TRUDI ZONE. THE CROSSHAIR DID NOT TURN YELLOW. THE EMITTER PAD DID NOT MOVE AND THE PATIENT DID NOT MOVE. THE ACCURACY WAS NOT WITHIN 2MM. THE INFORMATION INDICATED THAT THE TRUDI SUCTION DEVICE HAS BEEN REPROCESSED 7 TIMES VIA AUTOCLAVE. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. THE INVESTIGATION FINDING IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: A NON-STERILE 0-DEGREE TRUDI SUCTION WAS RECEIVED CONTAINED IN A DECONTAMINATION BAG. VISUAL INSPECTION WAS PERFORMED. NO 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 DEVICE WAS THEN CONNECTED TO THE TRUDI SYSTEM AND BROUGHT ABOVE THE EMITTER PAD (TRUDI ZONE), WHICH CAUSED THE STATUS BAR TO BE HIGHLIGHTED GREEN. DEVICE HAD NORMAL CONNECTION AND RESPONSE. IT INDICATED THAT THIS WAS ITS 9TH USE. ADDITIONALLY, A CUBE WAS REGISTERED ON THE TRUDI SYSTEM. THE SUCTION COMPLAINT DEVICE WAS HELD IN VARIOUS POSITIONS AROUND THE CUBE. SCREENSHOT IS AN EXAMPLE OF ONE OF THE POSITIONS HELD. THE DEVICE WAS HELD TO THE TIP WAS PERPENDICULAR AND TOUCHING A SIDE OF THE CUBE. DEVICE WAS PLACED IN SEVERAL AREAS TO SEE IF THE SENSOR LOCATION WAS ACCURATE. NO OBSERVATIONS OF INACCURACY WERE OBSERVED. THE REPORTED ISSUE COULD NOT BE CONFIRMED SINCE THE DEVICE PERFORMED WITHOUT ISSUES. IT IS POSSIBLE THAT OTHER FACTORS OR ISSUES MAY HAVE OCCURRED DURING THE USE OF THE DEVICE AND THESE ISSUES COULD NOT BE REPLICATED IN THE PRODUCT ANALYSIS LAB DURING THE ANALYSIS. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (2112100) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. AS PART OF THE CERENOVUS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. IT SHOULD BE NOTED THAT PRODUCT FAILURE COULD BE CAUSED BY MULTIPLE FACTORS. HOWEVER, THE INSTRUCTIONS FOR USE (IFU) STATES THAT BEFORE USE, CONFIRM THE TRUDI¿ NAV SUCTION¿S LOCATION ACCURACY BY CHECKING THE DISPLAYED POSITION OF THE TRUDI¿ NAV SUCTION ON SEVERAL CLEARLY IDENTIFIABLE ANATOMICAL STRUCTURES. 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. 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 (B)(6) 2022. THE RETURN 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 AN IN-OFFICE PRIMARY HYBRID BALLOON SINUPLASTY (BSP) PROCEDURE, THE 0° TRUDI NAV SUCTION DEVICE (TDNS000Z / 2112100) WAS INACCURATE ON THE TRUDI SYSTEM (S/N: (B)(4). THE SUCTION DEVICE WAS REPLACED AND THE ISSUE WAS RESOLVED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION ASSOCIATED WITH THE REPORTED INACCURACY ISSUE. ON 06-JUN-2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT WHEN THE ACCURACY ISSUE WAS OBSERVED, THE ICON ON THE TRUDI SYSTEM WAS GREEN. THERE WAS NO ERROR MESSAGE ON THE TRUDI NAVIGATION MONITOR FOR THE DEVICE. THE SUCTION DEVICE WAS PLUGGED IN AFTER REGISTRATION. THE PATIENT TRACKER WAS NOT MOVED AND THE PATIENT TRACKER CABLE WAS NOT UNDER TENSION IN RELATION TO THIS EVENT. COMPUTED TOMOGRAPHY (CT) IMAGE WAS USED AS THE PRIMARY IMAGE. THE CT SCAN CONTAINED 460 SLICES. THE INACCURACY ISSUE WAS DETERMINED BY COMPARING TRUDI PROBE. THERE WAS NO FERROMAGNETIC MATERIAL PLACED WITHIN THE TRUDI ZONE. THE CROSSHAIR DID NOT TURN YELLOW. THE EMITTER PAD DID NOT MOVE AND THE PATIENT DID NOT MOVE. THE ACCURACY WAS NOT WITHIN 2MM. THE INFORMATION INDICATED THAT THE TRUDI SUCTION DEVICE HAS BEEN REPROCESSED 7 TIMES VIA AUTOCLAVE. BASED ON THE ADDITIONAL INFORMATION THAT WHEN THE ACCURACY ISSUE WAS OBSERVED, THE ICON ON THE TRUDI SYSTEM WAS GREEN, THIS EVENT HAS BEEN DEEMED US-FDA MDR REPORTABLE AS A ¿MALFUNCTION.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262423 TRUDI SUCTION, 0 - 1PK TRUDI NAV SUCTION, 0 PGW ACCLARENT, INC. TDNS000Z 2112100 10705031245877

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown