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 Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/04/2020

Event Type  malfunction  

Event Description

It was reported that, during a cori installment, the camera had green lights on the back showing power/connection, but a red blinking light with audible beep on the front.When entering the camera diagnostic function within cori, the camera was not recognized.Cat5 cable was checked throughout the system and it did not show any visible defects.A new cat5 cable was tested which resulted in more of the same.No patient was involved.

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 established.Nothing visually contributed to the reported problem.A functional evaluation was performed.The reported problem was confirmed.The red blinking indicator was present.It is a result of a shock sensor that has been disabled due to the shock sensor battery loosing contact with the battery holder.The shock sensor was reset/enabled to clear the blinking indicator.A camera accuracy verification was performed and passed.The camera then functioned 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.The most likely cause can be attributed to the shock sensor becoming disabled during transportation.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.B5: update summary, d10: add concomitants, h6: update codes.

Event Description

It was reported that during a cori installment, the camera had green lights on the back showing power/connection, but a red blinking light with audible beep on the front.When entering the camera diagnostic function within cori, the camera was not recognized.Cat5 cable was checked throughout the system and it did not show any visible defects.A new cat5 cable was tested which resulted in more of the same.No patient was involved.No other complications were reported.

• 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: 10876078
• MDR Text Key: 217424422
• Report Number: 3010266064-2020-02028
• 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

• Is this an Adverse Event Report?: No
• 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: 11/18/2020
• Initial Date Manufacturer Received: 11/04/2020
• Initial Date FDA Received: 11/20/2020
• Supplement Dates Manufacturer Received: 10/22/2021
• Supplement Dates FDA Received: 10/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CORI ROBOTICS USA/(B)(6)