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

Model Number S7

Device Problems Unintended Arm Motion (1033); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information was not made available from the site.No procode, common device name and/or 510(k) provided as this device is not released for distribution in the united states.  return requested.Replacement device shipped to site 03/15/2017.No parts have been received by manufacturer for analysis.

Event Description

A medtronic representative reported that, while in a cranial biopsy procedure, the site attempted to attach an articulating arm in the aseptic field, however, the support arm was unstable and could not be fixed.The support arm was placed out of aseptic field to be checked and inspected.A second articulating arm was immediately sterilized and brought in to be used instead.No further details regarding the damage, or how it occurred, were provided.Delay in therapy was 5 minutes.The surgeon completed the procedure with the use of the navigation system.There was no impact on patient outcome.

Manufacturer Narrative

Additional information: device manufacturing date 12/05/2014.The hardware investigation of the returned articulating arm found that the reported event was related to a mechanical issue.This was a down revision component.The lot code indicates a manufacture date of july 2008.The handle of the arm was locked up with the arm in the released condition.The reported event was confirmed.This issue was documented in a medtronic navigation hardware anomaly tracking database.

• 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: amos jarrette ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902082
• MDR Report Key: 6481790
• MDR Text Key: 72790933
• Report Number: 1723170-2017-01030
• 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: 05/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: S7
• Device Catalogue Number: 9734056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2014
• 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