MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO SURGICAL SYSTEM BE/FR/DE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number NPFS02020

Device Problem Battery Problem (2885)

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

Event Date 04/07/2021

Event Type  malfunction  

Event Description

It was reported that, during a navio procedure, the led light above the battery icon was orange even after having plugged the navio into the wall for 24 hours.The procedure was successfully completed as intended and without delay.No patient injury or other complications were reported.

Manufacturer Narrative

H3, h6: the navio surgical system be/fr/de, product npfs02020, (b)(6) used for treatment was not made available to the designated complaint unit for evaluation thus, visual inspection and functional testing could not be performed.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 concluded this was an isolated event.A relationship between the reported event and the device could not be established as the product was not returned.Although the reported problem was not confirmed, a contributing factor may be ups battery failure.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.

• Brand Name: NAVIO SURGICAL SYSTEM BE/FR/DE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 11735138
• MDR Text Key: 248363605
• Report Number: 3010266064-2021-00311
• Device Sequence Number: 1
• Product Code: OLO
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NPFS02020
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKN NAVIO ROBOTICS INSTR