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

Catalog Number	FG200000
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hardware investigation has begun but it has not been completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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 biosense webster inc., or its employees that the report constitutes an admission that the product, biosense webster inc., 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
Event or Problem Description
It was reported that a patient underwent an ent (ear, nose & throat) procedure with a trudi¿ navigation system and the display monitor emitted smoke.It was reported by the caller that after booting up the trudi¿ navigation system the monitor display had lines on the bottom of the display and then 5 minutes later the monitor was smoking.The system was shot down and the monitor was removed and replaced with one from another system.Additional information was received indicating that the monitor was never on fire, but that the bottom corner looked like it had been smashed into something.The corner front ¿glass¿ part of the monitor was missing and the display components under it were smoking, so they turned it off and connected the display to a different monitor the hospital had on hand.When a different entc reconnected the damaged monitor the following day, it again smoked but did not have flames.
Additional Manufacturer Narrative
It was reported that a patient underwent an ent (ear, nose & throat) procedure with a trudi¿ navigation system and the display monitor emitted smoke.It was reported by the caller that after booting up the trudi¿ navigation system the monitor display had lines on the bottom of the display and then 5 minutes later the monitor was smoking.The system was shot down and the monitor was removed and replaced with one from another system.Device evaluation details: it was confirmed that the issue was resolved by replacing the damaged monitor and power cable with other ones that were delivered to the customer.The system is ready for use.The manufacturing record evaluation was performed on trudi system #400036, and no internal action related to the reported complaint condition were identified.The history of customer complaints reported during the last year and associated with trudi system #400036 was reviewed.No similar additional complaint was found.The complaint investigation results will be used for monitoring and detecting statistical signals per complaint trending and signal detection process.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• Brand Name: TRUDI¿ NAVIGATION SYSTEM
• Common Device Name: 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: 17778232
• Report Number: 2029046-2023-02129
• Device Sequence Number: 6736472
• Product Code: PGW
• UDI-Device Identifier: 10846835017182
• UDI-Public: 10846835017182
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K161701
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: FG200000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2023
• Supplement Date Received by Manufacturer: 10/29/2023
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown