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

Model Number ROB10024

Device Problem Failure to Power Up (1476)

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

Event Date 03/10/2021

Event Type  malfunction  

Event Description

It was reported that this cori demo system would not turn on when powered on prior to a demo last week.The front panel would not illuminate once the back power button was turned on.They were guided to removed the console cover and re-attached some connections within the console.These connections were found to be disconnected.They were able to reconnect and power on the system to conduct the demo.No case involved.

Manufacturer Narrative

H3, h6: the cori console p/n rob10024 (b)(6) intended for use in treatment was returned.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was confirmed.The console lcd screen is not functioning.After further dis-assembly the ribbon cable behind the lcd screen is disconnected and the connector latch is broken.A review of device records using the nc database(s), (legacy bbt, caweb4 and smartsolve) confirmed no abnormalities were reported on this device during manufacture.A complaint history review for similar reported/confirmed complaints has identified prior events.The most likely cause of this event was that the cable was not secured correctly in manufacturing.Based on the investigation, no further containment or corrective action is recommended or required 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
• MDR Report Key: 11612210
• MDR Text Key: 243733955
• Report Number: 3010266064-2021-00250
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757420
• UDI-Public: 00885556757420
• Combination Product (y/n): N
• PMA/PMN Number: K193120
• 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: 07/05/2021

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
• Device Operator: Health Professional
• Device Model Number: ROB10024
• Device Catalogue Number: ROB10024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Initial Date Manufacturer Received: 03/10/2021
• Initial Date FDA Received: 04/05/2021
• Supplement Dates Manufacturer Received: 07/03/2021
• Supplement Dates FDA Received: 07/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ROB20000, SERIAL: (B)(6).