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

Catalog Number	FG200000
Medical Device Problem Code	Image Orientation Incorrect (1305)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2023
Type of Reportable Event	Malfunction
Additional 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 #100121 was reviewed.3 similar complaints were found.The manufacturing record evaluation was performed on trudi system #100121, and no internal actions related to the reported complaint condition were identified.H9.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).
Event or Problem Description
It was reported that a patient underwent a functional endoscopic sinus surgery (fess) revision surgery with a trudi¿ navigation system and a location inaccuracy occurred.An issue was reported the trudi curette being "off" versus the suction device when compared head to head in the same anatomy.In this case, the curette was only off by 2mm versus the suction so was technically within our labeled specs - but the surgeon did not find the inaccuracy acceptable.There was no injury to patient.No concerns at all related to the patient health or safety.Troubleshooting was comparing the curette (which was appearing "off" embedded in the posterior table bone) directly in that same anatomy to the suction device.The surgeon who registered had been trained and had registered multiple times.Since the complaint is about the difference between curette and suction, registration is not the issue.The accuracy was confirmed using the registration probe after registration process was completed and with known landmarks in endoscopic visualization inside the nasal cavity.Inaccuracy was confirmed multiple ways during registration and on all areas of the face with the registration probe (rp) and then on the face with the instrument and then inside the nose on known landmarks throughout the rest of the case until getting to this anatomy.Suction was accurate, curette was accurate in most anatomy except for this one area.There were more than 100 ct sliced and the registration was accurate.Field of view was described as great.Reistration was not redone after identifying the issue.There is always a potential for metal interference in the operating room (or).This event was originally considered non-reportable, however, a product investigation identified a reportable product malfunction on 1-sep-2023.
Additional Manufacturer Narrative
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 h6.Investigation conclusions code from "cause traced to component failure (d02) to cause traced to software coding (d18).

• 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: 17839740
• Report Number: 2029046-2023-02186
• Device Sequence Number: 7389799
• Product Code: PGW
• UDI-Device Identifier: 10846835017182
• UDI-Public: 10846835017182
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• 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: 11/01/2023
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 11/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3005172759-09182023-001-
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TRUDI CURETTE; UNKNOWN REGISTRATION PROBE; UNKNOWN SUCTION DEVICE
• Patient Sex: Unknown