MAUDE Adverse Event Report: XOMED MICROFRANCE MFG IGS ENT SYSTEM; INSTRUMENT, STEREOTAXIC

Model Number	9733560XOMR
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.A medtronic representative went to the site to test the equipment.Testing revealed that the navigation system was found to be fully functional and the reported issue could not be replicated.The system then passed the system checkout and was found to be fully functional.A software analysis was initiated as part of the investigation.Analysis found that the behavior was consistent with a known anomaly in the medtronic navigation software anomaly tracking database.Concomitant medical products: other relevant device(s) are: product id: 9733467, serial/lot #: (b)(4).Product id: 9735001, serial/lot #: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system.It was reported that the mouse had not been working.This was reported outside of a procedure.There was no patient involved.It was reported that there has been no issues with the mouse since initial reporting.

• Brand Name: IGS ENT SYSTEM
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): XOMED MICROFRANCE MFG; saint-aubin-le-monial; bourbon-l'archambault 3160 ; FR 3160
• MDR Report Key: 11381176
• Report Number: 9680837-2021-00002
• Device Sequence Number: 17285180
• Product Code: HAW
• UDI-Device Identifier: 00613994594235
• UDI-Public: 00613994594235
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K001284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/25/2021

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 Expiration Date: 12/15/2014
• Device Model Number: 9733560XOMR
• Device Catalogue Number: 9733560XOMR
• Device Lot Number: 4500908579
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1