MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) SEE H10

Catalog Number 9735966

Device Problem Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 05/10/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.No brand name, procode, common device name and/or 510k provided as this device is not released for distribution in the united states.Lot no.And manufacture date not available for this instrument at time of filing.A medtronic representative went to the site to test the equipment.The hardware passed the system checkout.The imaging system then passed the system checkout and was found to be fully functional.No parts have been received by the manufacturer for evaluation.

Event Description

Medtronic received information regarding a navigation system.It was reported that two screws fell off as the monitor was being installed and the manufacturer representative was unable to find them.There was no patient present when this issue was identified.

• Brand Name: SEE H10
• Type of Device: H10
• 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: tiberious mose ; navigation customer quality; 826 coal creek circle; louisville, CO 80027
• MDR Report Key: 7571376
• MDR Text Key: 110219674
• Report Number: 1723170-2018-02530
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 06/05/2018

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
• Device Operator: Physician
• Device Catalogue Number: 9735966
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/10/2018
• Initial Date FDA Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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