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

Model Number	9733560XOMR
Medical Device Problem Code	Environmental Compatibility Problem (2929)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Onsite functional and visual examination was performed by a manufacturer representative.The system passed a system checkout and was determined to be fully operational.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation device being used outside of a procedure.It was reported that the site was having issues with their navigation system being able to turn on.It was also stated that the system would sometimes power down on them out of no where.There was no patient present at the time of the event.

• 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: 8934719
• Report Number: 9680837-2019-00002
• Device Sequence Number: 2041699
• Product Code: HAW
• UDI-Device Identifier: 00613994594235
• UDI-Public: 00613994594235
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 08/27/2019

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: 07/31/2011
• Device Model Number: 9733560XOMR
• Device Catalogue Number: 9733560XOMR
• Device Lot Number: 4500419325
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2019
• Initial Report FDA Received Date: 08/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1