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

Catalog Number	NPFS02000
Medical Device Problem Code	Computer Operating System Problem (2898)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, during a navio assisted surgery, an error appeared and the screen started having lines go across the screen that kept multiplying.It is unknown how the procedure was completed.The patient outcome is unknown.
Additional Manufacturer Narrative
H3, h6: the navio cpu, pn 220001, (b)(6), use in treatment, was returned for evaluation.The reported event was not confirm visually or functionally.The device was connected to a navio console, and advanced to the administrator screen for testing.The device passed testing and operated as design.No video or operation malfunction was observe.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, factors that may have contributed to the reported symptom may have been associated with failure of the video card or motherboard.A historical capa, nc, hhe/pra, field action review was completed.A review of prior escalation actions found no actions applicable to the scope of this case.The failure mode and associated risk have been anticipated within the risk file and that the documented risk level is still adequate.No further containment or corrective action is recommended or required at this time, all complaints are monitored through complaint investigation and post market surveillance activities.

• Brand Name: NAVIO SURGICAL SYSTEM US
• Common Device Name: 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: 13113048
• Report Number: 3010266064-2021-00917
• Device Sequence Number: 3537028
• Product Code: OLO
• UDI-Device Identifier: 00885556628416
• UDI-Public: 885556628416
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2022

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
• Operator of Device: Health Professional
• Device Catalogue Number: NPFS02000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2021
• Supplement Date Received by Manufacturer: 02/08/2022
• Initial Report FDA Received Date: 12/29/2021
• Supplement Report FDA Received Date: 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKN NAVIO ROBOTICS DEV/(B)(4).
• Patient Sex: Unknown