MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO HANDPIECE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number PFSR110137

Device Problem Electrical Shorting (2926)

Patient Problem No Patient Involvement (2645)

Event Date 01/27/2020

Event Type  malfunction  

Event Description

It was reported that hardware failed and error code 40000000000 showed up.No patient involved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Additional info: d11.

Manufacturer Narrative

Results of investigation: the device, intended to be used during treatment, was not returned for evaluation.There were also no photos returned of the device.There was no lot number provided for dhr review so it could not be concluded if the device met the manufacturing specifications.A complaint history review was performed and found similar reports of the issue.This issue will continue to be monitored.A relationship between the device and reported event has not been established.A factor that could have contributed to the reported event was that there was a blown fuse in the siu causing the error code.However, without the device for evaluation, the reported event cannot be confirmed.Therefore, the root cause of the reported event could not be determined.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: NAVIO HANDPIECE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 9999520
• MDR Text Key: 189197972
• Report Number: 3010266064-2020-01483
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628515
• UDI-Public: 00885556628515
• Combination Product (y/n): N
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/31/2020

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: Health Professional
• Device Model Number: PFSR110137
• Device Catalogue Number: PFSR110137
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/27/2020
• Initial Date FDA Received: 04/26/2020
• Supplement Dates Manufacturer Received: 08/11/2020; 08/11/2020
• Supplement Dates FDA Received: 08/11/2020; 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 220025 SIU, COMP CART; ROB00049 NAVIO SURGICAL SYSTEM