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

Model Number	ROB10025
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Failure to Calibrate (2440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a cori demo the real intelligence tracking camera had a soft bleep, and the led was red.The real intelligence tracking camera did not pass the initial test.As this happened in a demonstration, there was not patient involvement.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
Section h10: the real intelligence tracking camera (netherlands) rob10025, (b)(6), intended for use in treatment was returned for evaluation.A relationship between the reported event and the device was established.Nothing was identified visually that contributed to the reported problem.A functional evaluation was completed.The reported problem was confirmed.The camera was connected to a cori system.The front right led light was flashing red with an audible alert.The shock sensor was reset per procedure and the camera functions properly.The most likely cause of this event is the power source (battery) to the shock sensor circuit has disconnected itself from the shock sensor circuit during camera transport resulting in the front camera leds blinking red and an audible beep.Refer to the cori surgical system user¿s manual for proper handling.The robotics cart and accessories should be moved carefully over thresholds and bumps to avoid system damage.Exercise care during the surgical site setup, surgery and tear down to protect the device from an unforeseen force, such as falling onto a hard surface or damage.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 found similar prior events.A historical escalation event review was completed.A review of prior escalation actions found no actions applicable to the scope of this case.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.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.Internal complaint reference number: (b)(4).

• Brand Name: REAL INTELLIGENCE TRACKING CAMERA
• Common Device Name: 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: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14324700
• Report Number: 3010266064-2022-00346
• Device Sequence Number: 4697823
• Product Code: OLO
• UDI-Device Identifier: 00885556757437
• UDI-Public: 00885556757437
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K193120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/27/2022

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
• Operator of Device: Health Professional
• Device Model Number: ROB10025
• Device Catalogue Number: ROB10025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2022
• Supplement Date Received by Manufacturer: 05/25/2022; 07/25/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 05/26/2022; 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CORI ROBOTICS USA: ROB20000, SN: (B)(6).
• Patient Sex: Unknown