MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC CART 9733856 S7 STAFF ASSEMBLED 110V; EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT

Model Number 9733856

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/22/2020

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: 9733467, serial/lot #: (b)(4).A medtronic representative went to the site to test the equipment.It was reported that the hardware and software passed the system checkout.The system was found to be fully functional.Pending sw analysis.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system that was used during a functional endoscopic sinus surgery (fess) procedure.It was reported that the navigation system became unresponsive while the surgeon was navigating during the case.The system was rebooted and this resolved the issue.There was a reported delay of less than one hour.There is no known impact on patient outcome.

Manufacturer Narrative

Software analysis completed and it was reported that upon reviewing the logs, it was determined that this is an instance of testtrack #(b)(4).If information is provided in the future, a supplemental report will be issued.

• Brand Name: CART 9733856 S7 STAFF ASSEMBLED 110V
• Type of Device: EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 9688217
• MDR Text Key: 184150956
• Report Number: 1723170-2020-00425
• Device Sequence Number: 1
• Product Code: PGW
• UDI-Device Identifier: 00613994450944
• UDI-Public: 00613994450944
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9733856
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 91