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

Model Number ROB10024

Device Problem Unintended Application Program Shut Down (4032)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2020

Event Type  malfunction  

Event Description

It was reported that, during cori tka procedure system, upon shutting down the console it was prompted a ¿critical error¿.Surgery had been completed successfully without any delay.Patient was not harmed.

Manufacturer Narrative

H3, h6: the real intelligence cori, rob10024, serial number (b)(6) intended for used in treatment was not returned for evaluation.A visual or functional inspection could not be performed and the reported problem could not be visually or functional confirmed.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 has identified prior events.Although the reported problem was not confirmed, a contributing factor may be associated with a software bug.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.

• 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: richard confer ; 2828 liberty ave; suite 100; pittsburgh, PA 15222 ; 7634524980
• MDR Report Key: 10701253
• MDR Text Key: 212075321
• Report Number: 3010266064-2020-01891
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757420
• UDI-Public: 00885556757420
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1