MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STRAIGHT SUCTION 9733449 EM ENT; INSTRUMENT, STEREOTAXIC

Model Number	9733449
Medical Device Problem Codes	Material Integrity Problem (2978); Output Problem (3005)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No parts have been returned to the manufacturer for analysis.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding navigation devices being used for a functional endoscopic sinus surgery (fess) procedure.It was reported that one of the sites straight suctions had been drilled on and was damaged.The site was able to verify the suction but then had some issues tracking it.A clinical specialist (cs) was unable to replicate any tracking issues and suspected metal interference during the clinical case.It was noted that during the clinical case the surgeon proceeded with the suction.There were 4 scratches on the top of the suction, but the site was not pursuing a replacement at the time of report.It was also noted that a second straight suction wasn¿t verifying easily and was difficult.The procedure was completed with navigation and no surgical delay.There was no impact on patient outcome.A medtronic representative went to the site to test the navigation system.Testing revealed that the system was functioning normally.The system passed the system checkout and was found to be fully functional.

• Brand Name: STRAIGHT SUCTION 9733449 EM ENT
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8551169
• Report Number: 1723170-2019-01984
• Device Sequence Number: 313824
• Product Code: HAW
• UDI-Device Identifier: 00763000053369
• UDI-Public: 00763000053369
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 04/25/2019

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 Model Number: 9733449
• Device Catalogue Number: 9733449
• Device Lot Number: 181031
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 04/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 88