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

Model Number ROB10024

Device Problem Application Program Problem: Parameter Calculation Error (1449)

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

Event Date 06/05/2021

Event Type  malfunction  

Event Description

It was reported that during a cori lab/demo, when the pedal was not pressed down, the real intelligence cori recorded the leg going in hyper-extension due to trials not being in place.The information could not be corrected or overwritten even when recollecting the post-op baseline after clearing the values; therefore, it showed an incorrect range of motion information in the patient's file ((b)(4)).Moreover, real intelligence tablet flickered several times ((b)(4)).Since the issues occurred in a lab demo, there was no patient involvement.This is the third of three events.

Manufacturer Narrative

H3, h6.The real intelligence cori, pn: rob10024, sn: (b)(6) used for treatment was not returned to the designated complaint unit for evaluation, therefore visual and functional inspections could not be performed.The log files submitted were invalid and could not be reviewed.Therefore, the reported post-op baseline collection issues could not be confirmed.Based on the reported complaint, a possible contributing factor could be a stuck black foot pedal, preventing the user from recollecting, or the user had their foot on the black foot pedal as they entered post-op baseline and attempted to take the collection.This scenario was duplicated in a case where prior to entering post-op baseline collection screen, the black foot switch was pressed down and remained down while attempting to collect the baseline.The collection could not register.Therefore, it is possible that the user had the black foot pedal depressed when entering the post-op baseline collection screen, and remained depressed during collection, instead of depressing the foot pedal after having entered the post-op baseline collection screen.This situation is captured in the risk assessment released at the time of the complaint.The failure mode and associated risk have been anticipated within the risk file and that the documented risk level is still adequate.A review of manufacturing records indicate the software met all specifications upon release into distribution.A complaint history review found similar reports.A review of prior escalation actions was performed and found no actions that are applicable to the scope of the reported complaint.This issue will be continuously monitored through complaint investigation and post market surveillance.Based on the investigation, no containment or corrective actions are recommended at this time.

• Brand Name: REAL INTELLIGENCE CORI
• 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: 12044096
• MDR Text Key: 258977138
• Report Number: 3010266064-2021-00476
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757420
• UDI-Public: 00885556757420
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K193120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROB10024
• Device Catalogue Number: ROB10024
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/10/2022
• 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: A
• Patient Sequence Number: 1