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

Catalog Number ROB00043

Device Problem Application Program Problem: Parameter Calculation Error (1449)

Patient Problems Achalasia (1692); No Known Impact Or Consequence To Patient (2692)

Event Date 05/13/2020

Event Type  malfunction  

Event Description

It was reported that during the a tka procedure (bcs case), registration of the hip center, the neutral position error occurred. The camera position was moved, but the error did not disappeared. The navio was shut down and confirmed the correct registration of right/left, and tried neutral position collection again. However, the same error was displayed again so the doctor changed the tracker position, and the error message disappeared. The surgery was continued with navio with a delay of 15 minutes. No other complications were reported.

• 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
• Manufacturer (Section G): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer Contact: rick confer ; 2828 liberty ave; suite 100; pittsburgh, PA 38116 ; 4126833844
• MDR Report Key: 10121437
• MDR Text Key: 194121221
• Report Number: 3010266064-2020-01593
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/27/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: ROB00043
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse