MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STRAIGHT SUCTION, AXIEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	9733449
Medical Device Problem Code	Device Stops Intermittently (1599)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient weight not available from the site.Device manufacturing date is unavailable.The suspect suction was returned to the manufacturer for evaluation.It was reported that the suction would intermittently verify.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.
Event or Problem Description
A site representative reported that, while in a functional endoscopic sinus surgery (fess), the straight suction experienced difficulties verifying.It was noted that after verification, the suction would not track on the navigation system.There was a reported delay to the procedure of less than 1 hour due to this issue.There was no impact on patient outcome.No additional information was provided.
Additional Manufacturer Narrative
Additional information: device manufacture date provided.Correction: unique device identification (udi) updated to proper value.

• Brand Name: STRAIGHT SUCTION, AXIEM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7280875
• Report Number: 1723170-2018-00764
• Device Sequence Number: 956909
• Product Code: HAW
• UDI-Device Identifier: 00643169702851
• UDI-Public: 00643169702851
• 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,Followup
• Report Date (Section B): 03/09/2018

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: Physician
• Device Catalogue Number: 9733449
• Device Lot Number: 1710829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2018
• Initial Date Received by Manufacturer: 01/25/2018
• Supplement Date Received by Manufacturer: 02/26/2018
• Initial Report FDA Received Date: 02/19/2018
• Supplement Report FDA Received Date: 03/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1