MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE CORI; PRSTHSS,KNEE,FEMOROTIBIAL,NON-CNSTRND,CMNTD,METAL/POLYMER

Model Number PFSR101004

Device Problem Unintended Application Program Shut Down (4032)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/17/2020

Event Type  malfunction  

Event Description

It was reported that after a cori procedure, a message of system fault critical error would appear after the system was shut down were it indicated that the launcher exited due to a configuration error.The case was ran normally.No patient was involved at the time of the incident.No other complications were reported.

Manufacturer Narrative

H3, h6: the real intelligence cori, part number rob10024, serial (b)(6) and used for treatment, was not returned for evaluation.A relationship between the reported event and the device could not be established.A visual/functional inspection cannot be completed as no device was returned for evaluation.A review of manufacturing 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.While the reported problem was not confirmed during evaluation, the most probable contributing factor(s) to the reported problem is software issues.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 CORI
• Type of Device: PRSTHSS,KNEE,FEMOROTIBIAL,NON-CNSTRND,CMNTD,METAL/POLYMER
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 10487434
• MDR Text Key: 205475750
• Report Number: 3010266064-2020-01747
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00885556627747
• UDI-Public: 00885556627747
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PFSR101004
• Device Catalogue Number: ROB10024
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1