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

Catalog Number NPFS02000

Device Problem Misassembly by Users (3133)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case-(b)(4).

Event Description

It was reported that, during set up for a navio assisted pfa, they plugged the navio surgical system us without the monitor plugged in and could not get navio screens turned on.¿no signal detected¿ error screens populated on the monitor after 1 beep and then 4 additional beeps.They did a shut down and restart, same issue.They tried using a different outlet for the power cord, and had the same issue.They tried unplugging the plug inside the navio connected to the fuse box and plugging it into the wall outlet, and had same issue.They contacted robotics support and tried every option possible, and still having the same issue.The procedure was completed with manual instrumentation without significant delays.The patient was not harmed beyond the reported problem.After the case, they plugged the navio into the hallway outlet and somehow, the navio started working.

Manufacturer Narrative

The navio surgical system us, part number npfs02000, serial number (b)(6)., intended for treatment was not returned for evaluation.A relationship between the reported event and the device could not be established.A complaint history review for similar reported/confirmed complaints has identified prior events.A review of manufacturing records indicate the device met all specifications upon release into distribution.Refer to the navio surgical system user´s manual, section performing navio surgical system pre-operative setup & administrative procedures, powering the navio surgical system, turning on the navio surgical system for proper power on.The failure mode and associated risk have been anticipated within the risk file.The risk level is still adequate.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with a cpu that did not power on.Based on the investigation, the need for a corrective action is not recommended or required at this time.Should any additional information be received the complaint will be reopened.The failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.

• 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
• Manufacturer (Section G): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12964471
• MDR Text Key: 283158215
• Report Number: 3010266064-2021-00849
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628416
• UDI-Public: 885556628416
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NPFS02000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2021
• Initial Date FDA Received: 12/08/2021
• Supplement Dates Manufacturer Received: 08/04/2022
• Supplement Dates FDA Received: 08/09/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female