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

Model Number ROB10025

Device Problem Intermittent Communication Failure (4038)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/02/2020

Event Type  Injury  

Event Description

It was reported that during a cori xr tka procedure, they received the camera warming several times while in tibia cut screens.It would appear for several seconds, then go away (this reoccurring many times).In final screen, they could not see the tibia tracker.They confirmed the camera lenses were clear, trackers down and clean.They moved the camera and leg to several angles and could not see, but would occasionally notice flicker of femur and tibia during case.The procedure was changed to manual technique.No other complications were reported.

Manufacturer Narrative

G3, h2, h3, and h6: the cori camera p/n rob10025 s/n (b)(6) intended for use in treatment was returned for evaluation.A relationship between the reported event and the device was not established.Nothing visually contributed to the reported problem.A functional evaluation was performed.The reported problem was not confirmed.There was no camera warming messages and the camera detected trackers consistently during a mock saw bones case.A camera accuracy verification was performed and passed.The camera functioned as intended without any errors.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, an update to the software (1.4.1) has been released to resolve this issue.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.D8 and d9: device returned d10: add concomitants g1: address updated g2: report source update.

• Brand Name: REAL INTELLIGENCE TRACKING CAMERA
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 10610250
• MDR Text Key: 209337280
• Report Number: 3010266064-2020-01803
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757437
• UDI-Public: 00885556757437
• Combination Product (y/n): N
• PMA/PMN Number: K191223
• 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: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROB10025
• Device Catalogue Number: ROB10025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Date Manufacturer Received: 10/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CORI ROBOTICS USA/(B)(6)
• Patient Outcome(s): Required Intervention