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

Model Number BI70002000

Device Problems Loss of Power (1475); Failure to Power Up (1476); Difficult to Open or Close (2921)

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

Event Date 07/26/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information refused by site.Returned parts are pending analysis.

Event Description

Medtronic received information regarding an imaging system.It was reported during a sacroiliac and thoracolumbar spinal fusion procedure, the site had issues opening the gantry.While the site was taking 2d flouro shots a loud pop was observed and the imaging acquisition system (ias) lost power.The site was unable to turn the ias back on.The gantry was around a patient at the time the issue occurred.Via phone the manufacturer walked the site through the steps of manually opening the gantry.The site was also advised on how to disengage the clutch to manually move the system.There was a delay to the procedure of one hour.There was no reported impact on patient outcome.

Manufacturer Narrative

The door slides were returned to the manufacturer for analysis.The slides were found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.A battery charger was returned to the manufacturer for evaluation.Testing found that there was an open between a tray and connector.The imaging system power tray was returned tot he manufacturer for evaluation.Testing found an open fuse, that once replaced, the unit functioned as designed.The enclosure charger was returned to the manufacturer for evaluation.Significant electrical damages and overstress were noted, leading to functional testing not being performed.

Manufacturer Narrative

The analysis of the battery trays for the imaging system were completed by medtronic personnel.Testing found that both trays had multiple fuses open on the unit.Additionally it was noted that the voltage of the batteries was within specifications.

Manufacturer Narrative

The power conversion enclosure was returned to the manufacturer for analysis.Analysis found an electrical failure.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Device evaluation: the imaging system was returned to the manufacturer for analysis.Analysis found: mobile view station (mvs) sheet metal skins had scrapes; generator covers had scrapes; bellows had scrapes; x-stage cover had dents at the dock pin; front casters had broken wire stopper; rear wheels and axles had scrapes and paint chips; rotor axis motion was unable to move; display indicates door open condition; door operation was unable to open due to damage door cables; door operation was unable to close due to damage door cables; unable to perform 2d imaging as the rotor would not turn; unable to perform 3d imaging as the rotor would not turn, since display indicated door open condition.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding an imaging system.It was reported that intra/peri-operatively during a sacroiliac and thoracolumbar spinal fusion procedure, the site had issues opening the gantry.The site called in while trying to manually open the gantry to get assistance.The gantry was around a patient at the time.It was reported that the site was taking 2d flouro shots when they heard a loud pop and the imaging acquisition system (ias) lost power.They were then unable to turn the ias back on.Technical services walked the site through the steps of manually opening the gantry.The site said that they would call back if they had any issues.Technical services also advised the site on how to disengage the clutch to manually move the system.There was a delay to the procedure of one hour.There was no reported impact on patient outcome.

• 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: peter verhey ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7799698
• MDR Text Key: 117696178
• Report Number: 1723170-2018-04137
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BI70002000
• Device Catalogue Number: BI70002000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2016
• 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