MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. O-ARM; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE

Model Number MCT10

Device Problems Failure to Align (2522); Difficult to Open or Close (2921)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/22/2017

Event Type  malfunction  

Event Description

While in use in the operating room, o-arm would not open from a closed position after use.O-arm was able to be moved to the foot of the bed and a c-arm was used to complete the case.Manufacturer response for o-arm, mct10 (per site reporter): at the time of the event support personnel from medtronics was contacted and attempted to assist the staff remotely.The patient was safely removed from the o-arm and a c-arm was used during the remainder of the surgical procedure.The technician completed service to the o-arm.The rotor was in the lateral position with door slightly open leading to door alignment pins being misaligned and engaging the dingus and preventing the door from opening further.The system was rehomed and adjusted upper door switch which was maladjusted leading to original issue.The system was checked out and unit operating as expected.

• Brand Name: O-ARM
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 300 foster street; littleton MA 01460
• MDR Report Key: 6636420
• MDR Text Key: 77422678
• Report Number: 6636420
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Model Number: MCT10
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/31/2017
• Event Location: Hospital
• Date Report to Manufacturer: 05/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1