MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC CURVED SUCTION 90 9733451 EM ENT; INSTRUMENT, STEREOTAXIC

Model Number	9733451
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No parts have been received by the manufacturer for evaluation.Lot number and manufacture date were not available on the date of filing.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system.It was reported that during the verify instruments task of a fess procedure they were having trouble verifying some of their instruments.They tried two different trays, and some of the instruments were not verifying properly, while others (such as the straight suction) verified with no trouble.The site mentioned the 90 degree suction and ostium seeker, but there were others with problems as well.The site checked metal interference values, and they were less than 1.0.The site continued with instruments that they could verify.There was no reported impact on patient outcome.There was a delay to the procedure of less than one hour.Additional information was received: the two instruments involved were the 90 degree suction and the 70 degree suction.The manufacturer representative (rep) stated that the tips of the instruments looked bent and there was difficulty verifying the instruments.The instruments eventually verified.The rep stated he was told that the instruments would not verify properly.The rep stated that when he went to check the instruments they looked bent but were not bent enough to be considered damaged.The rep stated that he had no problem verifying the instruments when he checked them, and he has been in cases since this time and the instruments had been working without an issue.The site stated they would not replace the instruments at this time.

• Brand Name: CURVED SUCTION 90 9733451 EM ENT
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8564535
• Report Number: 1723170-2019-02041
• Device Sequence Number: 16252788
• Product Code: HAW
• UDI-Device Identifier: 00763000053383
• UDI-Public: 00763000053383
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 04/30/2019

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: 9733451
• Device Catalogue Number: 9733451
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 04/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 78