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

Model Number NPFS02000

Device Problems Application Program Problem (2880); Operating System Becomes Nonfunctional (2996)

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

Event Type  Injury  

Event Description

It was reported that the navio was powered on and the powered button beeped, the fan turned on, the dell splash screen appeared, and then the screen remained black.It was ensured that the power cord was secure and that all of the wires and connections in the back of the unit were secured.The system was powered on and off about 3 more times, all resulting in the same black screen.The procedure was completed as a manual procedure.

Manufacturer Narrative

H10: a1, d10, h3: updated information.H11: b1, b2, b5, d4, g5, h1, h6: corrected information.

Event Description

It was reported that, during an ukr surgery, the navio was powered on and the powered button beeped, the fan turned on, the dell splash screen appeared, and then the screen remained black.It was ensured that the power cord was secure and that all of the wires and connections in the back of the unit were secured.The system was powered on and off about 3 more times, all resulting in the same black screen.The navio was not used for this procedure.The case was done as a manual procedure.Surgery started late as consequence.The patient outcome is unknown.

Manufacturer Narrative

Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that the delay involved happened before the procedure started and no patient was involved, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

Manufacturer Narrative

H10: h3, h6: the device, intended to use in treatment, was not returned for evaluation.A relationship between the reported event and the device could not be established as the reported problem was not confirmed.A complaint history review found a similar report, 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.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.The root cause was established to be undetermined after investigation.No containment or corrective actions are recommended at this time.The surgical user's manual released at the time of the complaint (pn 500097 rev e) provides instructions for the user in the " troubleshooting information¿ section: " navio¿ surgical system does not start when is pressed on ups.- verify that the navio surgical system power cord is connected securely to the navio system cart and the power outlet." accordingly, product labeling has been ruled out as a cause of the complaint.The performed clinical / medical investigation indicates: " without supporting clinical/medical documents, a thorough investigation cannot be performed.The subject device was not made available to the designated complaint unit for evaluation and thus visual and functional inspection could not be performed.Factors that could have contributed to the reported issue are if the ups was not fully charged before use or if there was an issue with the cpu.The root cause was established to be undetermined after investigation.No containment or corrective actions are recommended at this 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: 8924194
• MDR Text Key: 155375196
• Report Number: 3010266064-2019-00110
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NPFS02000
• Device Catalogue Number: 220001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention