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

Model Number	9733449
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A medtronic representative went to the site to test the system the straight suction was used with.Testing revealed that the system performed as intended and no hardware parts were replaced.The system then passed the system checkout and was found to be fully functional.The instrument has not been returned, so no analysis has been conducted on it.Refer to mdr 1723170-2019-00614 for the report on the first straight suction.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
(b)(6) 2019, (b)(4) - (hcp, rep) medtronic received information regarding a navigation device being used for a functional endoscopic sinus surgery (fess) procedure.The issue occurred intraoperatively during the navigate task and caused no delay to the surgery.It was reported that the surgeon felt inaccurate with the straight suction (3 mm) but no other instrument.The surgeon aborted the use of the navigated suction and used a probe to confirm position.The medtronic representative noted that the suction did need slight manipulation to verify but only displayed a distance to divot around 2.1 mm before verification.The surgeon felt accurate after registration with an error metric of 2.1.The surgery was completed with navigation and there was no impact on patient outcome.

• 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: 8326974
• Report Number: 1723170-2019-00615
• Device Sequence Number: 2137928
• Product Code: HAW
• UDI-Device Identifier: 00613994378422
• UDI-Public: 00613994378422
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 02/11/2019

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: 17060848
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 02/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 84