MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO SURGICAL SYSTEM US; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number NPFS02000

Device Problem Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 12/27/2019

Event Type  malfunction  

Event Description

It was reported that the day after a case rep checked the system and upon booting up the battery icon immediately turned yellow and the icon next to it turned red.No patient involved.

Manufacturer Narrative

The device was intended to be used during treatment and was not returned for evaluation.The serial number was not provided for a dhr review.However, all lots distributed from the first inspection up until the complaint occurrence were reviewed and found no product issues related to the reported event.Therefore, the device met manufacturing specifications.A complaint history review was performed and found 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 could have been the internal battery of the ups was defective.However, without the actual device being evaluated, the issue could not be confirmed.The root cause of the reported event could not be determined.No corrective action or containment is recommended at this time.If the device is returned, the complaint will be re-investigated at that time.

• Brand Name: NAVIO SURGICAL SYSTEM US
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 9999156
• MDR Text Key: 188937893
• Report Number: 3010266064-2020-01358
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628416
• UDI-Public: 00885556628416
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/12/2020

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: NPFS02000
• Device Catalogue Number: NPFS02000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/27/2019
• Initial Date FDA Received: 04/25/2020
• Supplement Dates Manufacturer Received: 08/10/2020
• Supplement Dates FDA Received: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1