MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE FOOT PEDAL; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	ROB10026
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a sawbones trial in a cori-lab, they got an immediate shutdown of the system (leaving "blue man" icon on console) (b)(4) when pressing the center pedal button of real intelligence foot pedal.Repeatable within uka app, but then noticed the that footpedal cable was shorn and wires were exposed through insulation.After a new non-damaged pedal was used, the problem went away.When restoring the pedal of issue, the problem did not happen until the opening in the insulation was manipulated/pressed.They though that it was potentially a short of a 24v line, which would likely lead to that sort of shutdown.Upon inspection of the logs, there was no indication of the problem, which is the current design.However, a damaged footpedal cable (a likely situation in the field) would lead to this effect (b)(4).
Additional Manufacturer Narrative
H3, h6: the real intelligence foot pedal rob10026, (b)(6) intended for use in treatment was returned for evaluation.A relationship between the reported event and the device was established.The reported problem was visually confirmed.There is a 1 inch gash in the outer insulation just below the footswitch side strain relief.A functional evaluation was performed.The reported problem was confirmed.The footpedal was connected and a mock case attempted.When flexing the cable over the damaged area the blue man would display on the console.A review of manufacturing records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints concluded this was an isolated event.The most likely cause of this event was improper handling of the footswitch.A historical escalation event review was completed.A review of prior escalation actions found no actions applicable to the scope of the reported complaint.Care and caution should be exercised during the surgical site setup and tear down to protect the device cable and from sharp objects or from situations that pin the cable between two objects.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 FOOT PEDAL
• 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: 12243489
• Report Number: 3010266064-2021-00566
• Device Sequence Number: 5128009
• Product Code: OLO
• UDI-Device Identifier: 00885556757444
• UDI-Public: 00885556757444
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K193120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2022

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: ROB10026
• Device Catalogue Number: ROB10026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2021
• Supplement Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown