MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LITTLETON) O-ARM O2 IMAGING SYSTEM; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Catalog Number BI70002000

Device Problem Unintended Arm Motion (1033)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2016

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative inspected the imaging system on-site and a software investigation was completed.On-site, the reported behavior could not be replicated after extensive testing.The system functioned normally.The software investigation also proved inconclusive.The logs for this date were examined to investigate the incident.The exact time of the incident was not given.In the logs, there were no warnings or errors that would help diagnose the incident.The drive system was manufactured by (b)(4).The imaging system does not get status reports from (b)(4)¿s drive system.The (b)(4) drive system did not provide any information to help diagnose the incident.It is not possible to determine root cause without further information.A full imaging system check-out was completed and all tests passed.Full system functionality was confirmed and the system was returned to service.No further issues reported.

Event Description

A medtronic representative reported that during a spinal fusion procedure, the imaging system was not driving as expected.It was reported that when the drive handle was pushed down to move the system backwards, it unexpectedly moved forward and impacted the patient bed.The contact with the bed damaged the imaging system cover.The clutch was disengaged and the system was manually moved away from the bed and out of the operating room.Outside the operating room, the clutch was re-engaged and the issue recurred.At this point, the system was docked.After the system was docked, the issue could not be replicated.This issue occurred after the final confirmation spin in the case, while removing the system from the room.The patient was not impacted by this, and the delay was minimal (less than one hour).No additional details were provided.

• Brand Name: O-ARM O2 IMAGING SYSTEM
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LITTLETON); 300 foster street; littleton MA 01460
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LITTLETON); 300 foster street; littleton MA 01460
• Manufacturer Contact: nicholas mcnabb ; 826 coal creek circle; louisville, CO 80027 ; 7208902439
• MDR Report Key: 5761476
• MDR Text Key: 48536533
• Report Number: 1723170-2016-01269
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151000
• 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: 06/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Equipment Company Technician/Representative
• Device Catalogue Number: BI70002000
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2016
• 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: 61 YR
• Patient Weight: 113