MAUDE Adverse Event Report: BIOSENSE WEBSTER INC TRUDI¿ NAVIGATION SYSTEM; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT

Catalog Number FG200000

Device Problem Image Orientation Incorrect (1305)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/18/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an ear, nose & throat procedure (ent) procedure with a trudi¿ navigation system and a location inaccuracy occurred.It was reported that the trudi curette was reading inaccurately in the brain when compared to the trudi suction device in the same position.The procedure continued without resolution.Additional information received indicated a location inaccuracy was determined only in this one area of anatomy in the middle of the workflow of the case.It was determined from the curette reading significantly differently from suction in same exact anatomy.Additionally, the curette was depicted in brain 4mm across the skull base bone -rather than in nasal cavity where surgeon was operating.Accuracy had been previously validated by both using the registration probe and through instrumentation.The registration was performed by a fellow and was good.Accuracy was confirmed on four (4) areas of the face and then intranasally on known, fixed landmarks such as back of maxillary, face of sphenoid.Many ct scans at 0.75mm scan thickness and nearly whole-head computed tomography(ct).Field of view was reported to be great at in angled scope.There were no noticeable defects on the ct scanned images.The trudi¿ navigation system did not indicate any metal interference.The or table was in question since this is the closest point of patient anatomy to the table since they tilt the patient head back.However, that does not explain suction being ¿on¿ and curette ¿off¿.It was reported non-acclarent devices were used, and it was considered the acclarent devices did not function as expected.There was no patient consequence and no medical intervention was required.This event was originally considered non-reportable, however, a product investigation identified a reportable product malfunction on 1-sep-2023.

Manufacturer Narrative

Device investigation details: an investigation was initiated by the manufacturer to investigate the issue.A software defect was discovered which affects the location accuracy of the curette tool on the trudi system display.The issue is being addressed as part of an internal corrective action.The history of customer complaints reported during the last year associated with trudi system #(b)(6) was reviewed.3 similar complaints were found.The manufacturing record evaluation was performed on trudi system #(b)(6), and no internal actions related to the reported complaint condition were identified.9.Fda correction/ removal reporting no: 3005172759-09182023-001-c.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

The manufactured date has been provided.Therefore, field h4.Device manufacture date has been populated.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) on 1-nov-2023, the product investigation was reopen to correct the following information: field h6.Investigation conclusions code corrected from "cause traced to component failure (d02) to cause traced to software coding (d18).Also, it was previously reported the history of customer complaints identified 3 similar complaints, however, it was updated to 5 similar complaints.

• Brand Name: TRUDI¿ NAVIGATION SYSTEM
• Type of Device: EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (IRVINE); 33 technology drive; irvine CA 92618
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17839407
• MDR Text Key: 324575931
• Report Number: 2029046-2023-02194
• Device Sequence Number: 1
• Product Code: PGW
• UDI-Device Identifier: 10846835017182
• UDI-Public: 10846835017182
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161701
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FG200000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/01/2023
• Initial Date FDA Received: 09/28/2023
• Supplement Dates Manufacturer Received: 11/01/2023
• Supplement Dates FDA Received: 11/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 3005172759-09182023-001-
• Patient Sequence Number: 1
• Treatment: TRUDI CURETTE