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

Model Number	9734308
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No devices were 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 intra/peri-operatively of a functional endoscopic sinus surgery (fess) procedure.It was reported that the straight suction was damaged and was found during a case.The suction was visibly bent so the site used another suction to complete the procedure.There was no delay in the procedure and no impact on patient outcome.

• Brand Name: SMALL STRAIGHT SUCTION
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9602061
• Report Number: 1723170-2020-00175
• Device Sequence Number: 16725947
• Product Code: HAW
• UDI-Device Identifier: 00613994844712
• UDI-Public: 00613994844712
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 01/17/2020

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: 9734308
• Device Catalogue Number: 9734308
• Device Lot Number: 17040452
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2019
• Initial Report FDA Received Date: 01/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 4 YR
• Patient Weight: 18