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

Catalog Number NPFS02000

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/27/2020

Event Type  malfunction  

Event Description

It was reported that before a navio procedure, the camera was plugged in for 10 minutes but would not connect on screen after pressing begin operation.The drill and switch pedal connected immediately, but the busy circle kept spinning.The lights were present on the camera (not sure which ones were lit or blinking), said color was green.They disconnected the camera cord, re-started navio, but the issue was not resolved.They swapped the camera for its backup and continue the procedure with a delay of less than 30 minutes.No other complications were reported.After the case, the usb connector at the back of the computer was checked and when the camera was connected to another port on the computer, it worked.

Manufacturer Narrative

H6: the navio surgical system (us), product npfs02000, sn (b)(6) used for treatment was not returned for evaluation; thus, a visual and functional evaluation could not be performed, and a relationship between the reported event and the device could not be determined.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.Although the reported problem was not confirmed, a contributing factor may have been associated with a defective usb port for the camera cord resulting in a connection issue.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.D10: add concomitants g1: address updated.G4: add 510k code.H6: code update.

• 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: 10564592
• MDR Text Key: 207906030
• Report Number: 3010266064-2020-01786
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628416
• UDI-Public: 885556628416
• Combination Product (y/n): N
• PMA/PMN Number: K152574
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NPFS02000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CABLE, CAMERA CART, NAVIO/UNK; NDI CAMERA POLARIS SPECTRA/UNK; UNKN NAVIO ROBOTICS INSTR/UNK