MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC FUSION COMPACT; EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT

Model Number 9735602

Device Problem Imprecision (1307)

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

Event Date 08/22/2019

Event Type  malfunction  

Manufacturer Narrative

Device unique identifier (udi) unavailable.A medtronic representative went to the site to test the equipment.Testing revealed that there was an alleged inaccuracy with the 70 degree instrument, but the issue was resolved by reinstalling the software applications.The system then passed the system checkout and was found to be fully functional.Device manufacturing date is unavailable.Other relevant device(s) are: software 9735638 fusion compact ent.If information is provided in the future, a supplemental report will be issued.

Event 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 site was using the navigation system for the first time.The manufacturing representative installed the software prior to the case and ensured that the needed tools were present.During the case, the surgeon noticed that the 70 degree balloon instrument was off by 1 cm posterior of the physical location in the patient.This issue only occurred with multiple 70 degree instrument and all the other instruments and balloons navigated accurately.The site re-registered the patient and did not resolve the issue.The surgeon continued to use the 70 degree balloons non-navigated but continued to navigate with all the other instruments.The manufacturing representative brought in another navigation system for the following cases and the 70 degree balloons worked without any issues.There was a less than 1-hour delay to the procedure and no impact on patient outcome.

Manufacturer Narrative

Analysis on the software was determined to be inconclusive as the issue was resolved by re-installing the software and the issue could not be replicated.If information is provided in the future, a supplemental report will be issued.

• Brand Name: FUSION COMPACT
• 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: 9076213
• MDR Text Key: 159123808
• Report Number: 1723170-2019-04909
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153247
• 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: 11/01/2019

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
• Device Operator: Health Professional
• Device Model Number: 9735602
• Device Catalogue Number: 9735602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2019
• Initial Date FDA Received: 09/17/2019
• Supplement Dates Manufacturer Received: 10/07/2019
• Supplement Dates FDA Received: 11/01/2019
• 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: 49 YR
• Patient Weight: 82