MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) FUSION NAVIGATION SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number FUSION

Device Problem Imprecision (1307)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.A medtronic representative went to the site to test the equipment.The representative reported that they could verify the suspect instrument but not a second instrument.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.No parts have been received by the manufacturer for evaluation.

Event Description

A site representative reported that, while in a functional endoscopic sinus surgery (fess), the site were unable to verify the suctions used accurately.It was noted that the suctions were not passing accuracy checks.The surgeon then opted to complete the procedure with the inaccurate instruments.

• Brand Name: FUSION NAVIGATION SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: peter verhey ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7126209
• MDR Text Key: 95457561
• Report Number: 1723170-2017-05200
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994380005
• UDI-Public: 00613994380005
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/18/2017

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: Physician
• Device Model Number: FUSION
• Device Catalogue Number: 9733560XOM
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2017
• Initial Date FDA Received: 12/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2010
• 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