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

Catalog Number ROB00043

Device Problem Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Date 02/17/2020

Event Type  malfunction  

Event Description

It was reported that, upon testing the navio cart, it was not booting up even though the transformer was connected and powered on.When the connector of cable on cart connected to the transformer was moved slightly, navio responded.But after that, navio did not respond again.It was doubted that the connection part of cable on cart had something wrong.As this happened upon testing in the warehouse, before releasing the unit for distribution to the client, no case was involved.

Manufacturer Narrative

Memo for the submission added - attachment: [memo - mdr submissions.Pdf].

Manufacturer Narrative

The device, intended to use in treatment, was returned for evaluation.A relationship between the reported event and the device was established as the reported problem was confirmed.A complaint history review found similar reports.The dhr could not be reviewed and it was not confirmed if the product met manufacturing specifications.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.Visual inspection found the exterior condition shows minor wear (scuffs).Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed and the reported complaint was confirmed.The ups, ous when hooked up to a power supply is not responding or powering on.When pushing the power button a click sound can be heard along with a green led by the battery for 2 seconds.No other functions could be tested.The root cause was established to be supplier / raw material fault.

• Brand Name: NAVIO SURGICAL SYSTEM JAPAN
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 9999757
• MDR Text Key: 188983945
• Report Number: 3010266064-2020-01513
• Device Sequence Number: 1
• Product Code: OLO
• 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: 08/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ROB00043
• Date Manufacturer Received: 08/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1