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

Model Number	9733449
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/19/2018
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 a navigation device being used for a functional endoscopic sinus surgery (fess) procedure.It was reported that the site struggled to verify the straight suction.It was noted that its tracking was inconsistent.The site used a malleable suction and later were able to verify the straight suction.There was no patient impact reported and a less than one hour delay to surgery.
Additional Manufacturer Narrative
The straight suction was returned to the manufacturer for analysis.Analysis found that the returned straight suction was not able to verify when attached to a known good tracker, returning a divot error of 2.6 mm to 2.8 mm.It failed an iqa divot test with a divot error of 2.7.The ss tip was not physically damaged or dented.No runout noted.Analysis found that the reported event was related to a mechanical issue.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STRAIGHT SUCTION
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8215741
• Report Number: 1723170-2019-00076
• Device Sequence Number: 11238504
• Product Code: HAW
• UDI-Device Identifier: 00643169702851
• UDI-Public: 00643169702851
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K050438
• 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,Followup
• Report Date (Section B): 02/05/2019

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: 18082202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2018
• Supplement Date Received by Manufacturer: 01/18/2019
• Initial Report FDA Received Date: 01/03/2019
• Supplement Report FDA Received Date: 02/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 75