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

Catalog Number BI70002000-G30

Device Problems Bent (1059); Break (1069); Mechanical Problem (1384); Positioning Problem (3009)

Patient Problem No Patient Involvement (2645)

Event Date 02/15/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.A manufacturer representative went on-site to conduct visual and functional testing.Three parts, two caster mounts and one cover, were reported as damaged and replaced.System checkout was successful.The three parts were returned to the manufacturer for further analysis.All parts went through functional and visual examination.Testing confirmed that on the two caster mounts the docking pin had broken off and the pin was stuck in the mount.Testing confirmed damage structural damage to the cover at the panel docking pin holes.Parts were replaced on-site, no further action needed.

Event Description

Medtronic received information regarding an imaging device.It was reported that the docking pins and docking mechanism were damaged.This was observed outside of a surgical procedure.No patient involvement.

Manufacturer Narrative

Correction: changed the udi number to the correct information.Added information on initial reported.Udi updated to reflect correct system information report source changed from health professional to company representative to reflect the event more accurately.Added mechanical problem results code to more accurately represent findings.

• 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: stephanie riley ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7635267745
• MDR Report Key: 7634193
• MDR Text Key: 112195628
• Report Number: 1723170-2018-02965
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Catalogue Number: BI70002000-G30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/21/2018
• Initial Date FDA Received: 06/25/2018
• Supplement Dates Manufacturer Received: 09/17/2018
• Supplement Dates FDA Received: 09/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2017
• 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