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

Catalog Number BI70002000-G27

Device Problem Difficult to Open or Close (2921)

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

Event Date 06/19/2018

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.Testing revealed that the rotor got stuck due to excessive force to open the gantry door manually.The dingus was stuck about 12" away from home position.The jammed rotor was freed and installed new door winch assembly.Adjusted gantry door and tested the system.The imaging system then passed the system checkout and was found to be fully functional.No parts have been returned to the manufacturer for evaluation.

Event Description

Medtronic received information that the image acquisition system (ias) gantry would not open while being wrapped around a patient.Unable to manually open it per the field service engineer (fse).There was no reported impact on patient outcome.

Manufacturer Narrative

Event description has been updated.Initial reporter updated to proper value.Device evaluation: the door winch assembly was returned to the manufacturer for analysis.Analysis was unable to confirm the reported complaint.The door winch assembly passed both visual inspection and performance testing.The motor rotated forward and backwards with the brake engaging and disengaging as normal.It was determined the motor functioned as expected.Analysis found no fault with the returned door winch assembly.If information is provided in the future, a supplemental report will be issued.

Event Description

It was noted that navigation and imaging were aborted due to this issue.There was also a reported surgical delay of less than 1 hour due to the issue.

• 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: tiberious mose ; navigation customer quality; 826 coal creek circle; louisville, CO 80027
• MDR Report Key: 7687816
• MDR Text Key: 114019622
• Report Number: 1723170-2018-03425
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00643169639683
• UDI-Public: 00643169639683
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: BI70002000-G27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2016
• 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: 72 YR
• Patient Weight: 44