MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE ROBOTIC DRILL ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number ROB10013

Device Problem Fitting Problem (2183)

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

Event Date 09/13/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that when inserting the bur during the setup phase during a cori assisted ukr surgery, a system time out (the robotic drill has been deactivated) message prompted after pressing the ¿unlock¿ button ((b)(4)). Multiple attempts to recover were conducted including pressing ¿continue¿, ¿quit¿ and exiting out of the case and resuming the case. They disconnected the drill multiple times and had an equipment swap with two drills. The same error messages continued to persist and a full reboot of the system was conducted with no resolution ((b)(4)). A "communication failure" message and an internal error (the system has detected the application unexpectedly exited) were prompted ((b)(4)). They presumed that there was a connection problem associated with the console. So they borrowed a new cori console and tray from a nearby facility. They plugged in two of the previous "bad drills" into the brand new console and the error message still prompted. Therefore, the issue was caused by the drills and not the console ((b)(4)). To recover they used a new drill from a different facility and plugged that in to the new console and they were able to proceed with the case. The procedure was completed with a delay of over one hour with the patient under anesthesia and open on the table by using the s+n back-up device. The outcome of the patient¿s surgery was successful and there was no harm to the patient due to this error.

• Brand Name: REAL INTELLIGENCE ROBOTIC DRILL
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 12544011
• MDR Text Key: 282416897
• Report Number: 3010266064-2021-00679
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K201022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 09/28/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: ROB10013
• Device Catalogue Number: ROB10013
• Was Device Available for Evaluation?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No