MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) CART 9734056 S7 STAFF SHRT 100-120V INTL SEE H10)

Model Number S7

Device Problem Device Stops Intermittently (1599)

Patient Problem No Patient Involvement (2645)

Event Date 08/19/2017

Event Type  malfunction  

Manufacturer Narrative

Correction: device manufacture date updated to proper value.

Manufacturer Narrative

No procode, common device name, udi and/or 510(k) provided as this device is not released for distribution in the united states. This complaint was initially assessed as a non-reportable malfunction with the information available. The mdr decision was reversed based on evaluation of returned axiem system on (b)(6) 2018. The hardware investigation of the returned axiem box found that the reported event was related to an electrical issue. Port 4 stayed amber when an instrument was inserted in the port, and tracking details reported not used. Eminterface reported a fault on the instrument. Port 8 was eratic and intermittent when first inserted the instrument, after 5 minutes tracking details stayed red with a poor signal error. Eminterface reported that coil 2 was not functioning. The reported event was confirmed. This issue was documented in a medtronic navigation hardware anomaly tracking database. A medtronic representative went to the site to test the equipment and replace the axiem box. The hardware, software, and instruments passed the system checkout. The system was found to be fully functional.

Event Description

A medtronic representative reported that a port did not verify upon using the em controller. They used a different working port. There was no patient present when this issue was identified.

• Brand Name: CART 9734056 S7 STAFF SHRT 100-120V INTL
• Type of Device: SEE 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: peter verhey ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902082
• MDR Report Key: 7229509
• MDR Text Key: 103062203
• Report Number: 1723170-2018-00464
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10)
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 02/07/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Equipment Company Technician/Representative
• Device Model Number: S7
• Device Catalogue Number: 9734056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse