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

Model Number	ROB10026
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during preventative maintenance of cori, they entered an existing test case and the pedal would not connect.Therefore, they unplugged and re-plugged the pedal, but the connection light would not light up.So, they powered down system, restarted and created new test case.The pedal connected at connection screen, and they advanced to bur options, but a pedal disconnection pop-up.They unplugged and re-plugged to clear it, but it took multiple tries.There was no patient involvement.No other complications were reported.
Additional Manufacturer Narrative
H3, h6: the cori footswitch p/n rob00026 (b)(6) used for treatment was returned.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The evaluation followed performance verification for the footswitch.The reported problem was not confirmed.The footswitch tested and ran through the steps and functioned properly with no defects.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, no reasonable contributing factors could be identified based on the received complaint information and investigation results.Based on the investigation, no further containment or corrective action is recommended or required at this time.

• 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
• MDR Report Key: 11646962
• Report Number: 3010266064-2021-00272
• Device Sequence Number: 19753962
• Product Code: OLO
• UDI-Device Identifier: 00885556757444
• UDI-Public: 00885556757444
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2021

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
• Operator of Device: Health Professional
• Device Model Number: ROB10026
• Device Catalogue Number: ROB10026
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/18/2021
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 04/11/2021
• Supplement Report FDA Received Date: 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1