MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE 24 IN. TOUCH SCREEN; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number ROB10003

Device Problem No Display/Image (1183)

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

Event Date 12/18/2020

Event Type  malfunction  

Event Description

It was reported that, before starting a tka cori procedure, the 24¿ monitor was not showing start screen as seen on tablet.The bottom right corner had a red light.After multiple attempts, the control buttons finally illuminated to hit blue power.Red light turned green, monitor displayed no signal, then light turned back to red.After a few attempts, system was fully shut off and restarted.This time 24¿ monitor showed a screen.Once they started case, monitor blanked out again after viewing trackers position to adjust camera.Could not get a feed to it.Tried everything and just went from red, green, no signal, back to red.Shut down system to hook up dvi to external monitor jack and couldn¿t get a feed.Ended up switching monitors from other system, powering up cori and resuming operation.This event contributed to surgical delay of more than 30 min.Patient was not harmed.

Manufacturer Narrative

H3, h6: the real intelligence 24 inch touch screen, part rob10003, s/n (b)(6) used for treatment was not made available to the designated complaint unit for evaluation thus, a visual and functional evaluation could not be performed.A relationship between the reported event and the device could not be established as the product was not returned.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.Although the reported problem was not confirmed, a factor that may have contributed to the reported symptom may have been associated with component 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 or provided at a future date, this evaluation will be reopened for investigation.

• Brand Name: REAL INTELLIGENCE 24 IN. TOUCH SCREEN
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 11159224
• MDR Text Key: 226551816
• Report Number: 3010266064-2021-00038
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556756256
• UDI-Public: 00885556756256
• Combination Product (y/n): N
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROB10003
• Device Catalogue Number: ROB10003
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1