MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE ROBOTICS CART BASE 220; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	ROB100022
Medical Device Problem Codes	Failure to Power Up (1476); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during set up for a cori demonstration, sparks were seen coming from the transformer underneath and to the rear of the real intelligence robotics cart base 220.Then, the real intelligence cori then failed to turn on.No case involved; therefore, there was no patient involvement.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
Results of investigation: the product, real intelligence robotics cart base 220, rob100022, s/n (b)(6), intended for use in treatment was not returned for evaluation, however a phone interview with the uk technical support team was conducted.A relationship between the reported event and the device was established.The reported problem was visually and functionally confirmed.Sparks were seen below the base when the cori power cord was plugged into wall power.The cori power cord was replaced and the system powers up with no issues.The most likely cause of the event is product mishandling.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 one similar event.A historical escalation event review was completed.A review of prior escalation actions found no actions applicable to the scope of the reported complaint.Refer to the cori instructions for use for proper handling.Care and caution should be exercised when storing the power cord and moving the cori product between locations.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.

• Brand Name: REAL INTELLIGENCE ROBOTICS CART BASE 220
• 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: 13975513
• Report Number: 3010266064-2022-00236
• Device Sequence Number: 6284572
• Product Code: OLO
• UDI-Device Identifier: 00885556774151
• UDI-Public: 885556774151
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K193120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2022

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 Catalogue Number: ROB100022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2022
• Supplement Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 04/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/05/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: REAL INTELLIGENCE CORI-SN (B)(6); ROB10024, REAL INTELLIGENCE CORI
• Patient Sex: Unknown