MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE TABLET; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	ROB10027
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference number: (b)(4).
Event or Problem Description
It was reported that, during a cori assisted surgery, the real intelligence tablet kept blacking out.The procedure was completed with the monitor with a significant delay.The patient was not harmed beyond the reported problem.
Additional Manufacturer Narrative
Internal complaint reference number: (b)(4).Section d4 was corrected.
Additional Manufacturer Narrative
H3, h6: the real intelligence tablet, rob10027, sn: (b)(6), used in treatment was returned for evaluation.A relationship between the reported event and the device was established.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was confirmed.The tablet was connected to a cori console and advanced to the administrator screen for set up, however when the tablet cable was flexed, the tablet blackout/flicker occurred.The tablet blacked out for approximately 10 seconds and during this period, the led indicator flashed continuously until the screen reappeared.When a drill connector contacted the console drill port, the tablet blackout/flicker did not occur.Additionally, the tablet was monitored for one hour.The tablet blackout/flicker did not occur during this time.The most likely cause of this event is esd interference and/or signal noise resulting in sporadic tablet blackout periods to prevent current overload.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 found similar events.A historical escalation event review was completed.The review determined that prior escalation actions are applicable to the scope of this complaint and further investigation into the reported failure is being conducted to determine if additional escalation actions are required.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.The failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.
Additional Manufacturer Narrative
H3, h6: the real intelligence tablet, rob10027, sn (b)(6), used in treatment was returned for evaluation.A relationship between the reported event and the device was established.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was confirmed.The tablet was connected to a cori console and advanced to the administrator screen for set up, however when the tablet cable was flexed, the tablet blackout/flicker occurred.The tablet blacked out for approximately 10 seconds and during this period, the led indicator flashed continuously until the screen reappeared.When a drill connector contacted the console drill port, the tablet blackout/flicker did not occur.Additionally, the tablet was monitored for one hour.The tablet blackout/flicker did not occur during this time.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 found similar events.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.A historical escalation event review was completed.The review determined that prior escalation actions are applicable to the part number or serial number and scope of this complaint, and no further escalation action is required.The most likely cause of the reported issue is related to esd interference and/or signal noise which caused the tablet to shut off to prevent current overload.Initial changes were implemented with a firmware and cable update and additional corrective actions have been initiated.The failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.

• Brand Name: REAL INTELLIGENCE TABLET
• 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: 14489181
• Report Number: 3010266064-2022-00383
• Device Sequence Number: 5322807
• Product Code: OLO
• UDI-Device Identifier: 00885556757451
• UDI-Public: 00885556757451
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K193120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/07/2025

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 Model Number: ROB10027
• Device Catalogue Number: ROB10027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2022
• Supplement Date Received by Manufacturer: 06/22/2022; 08/29/2022; 03/06/2025
• Initial Report FDA Received Date: 05/24/2022
• Supplement Report FDA Received Date: 06/27/2022; 08/30/2022; 03/07/2025
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ROB20000/(B)(6)- CORI ROBOTICS USA.
• Patient Sex: Unknown