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

Catalog Number NPFS02070

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2019

Event Type  malfunction  

Event Description

It was reported that a pre-surgery test boot revealed an error with the ups: a red light on ups and error on system monitor ¿ups backup battery not working properly; error code 2000000000000".The error only tripped upon turning on of the pc, but was impassable.When the usb link to the ups cable was unplugged the error light did not appear on the ups, although the pc was powered up and ups under full load.The batteries were fully charged.The equipment was later swapped out.No patient involved.

Manufacturer Narrative

The device, intended for 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, this issue will continue to be monitored.There was no lot number noted in the initial investigation documents so we are unable to conduct a dhr review as a part of the investigation.It was not confirmed if the product met manufacturing specifications.Visual inspection found that the exterior condition of the device doesn't show any wear.Nothing was identified visually that could contribute to the reported problem.In addition, a visual inspection was performed on the part beyond the reported complaint.There were no additional visual observations identified.A functional evaluation was also performed and the reported problem was confirmed.The ups was not functioning.When plugged in for 4 hours, just clicked during the charging cycle.Charge led does not acknowledge the charging process.Ups will not power up.Based on previous complaints it is reasonable to suggest this is an internal electronics issue.Ups cannot be investigated further due to broken/damaged parts.Therefore, the root cause was established to be supplier / raw material fault.No containment or corrective actions are recommended at this time.

• Brand Name: NAVIO SURGICAL SYSTEM AU
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 9999462
• MDR Text Key: 189162761
• Report Number: 3010266064-2020-01450
• 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
• Report Date: 08/10/2020

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 Catalogue Number: NPFS02070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Initial Date Manufacturer Received: 11/21/2019
• Initial Date FDA Received: 04/26/2020
• Supplement Dates Manufacturer Received: 08/05/2020
• Supplement Dates FDA Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1