MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES CABLE, CAMERA CART, NAVIO; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 200028

Device Problem Intermittent Communication Failure (4038)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/02/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case- (b)(4).

Event Description

It was reported that during set up for a navio assisted tka surgery, the foot pedals and camera cord were plugged in.A case was created for the total knee procedure.On the connection screen, both foot pedals were connected but the camera was not connecting.They made sure the camera cord was connected both into the robot and into the camera, and the camera was still not connecting.They proceeded to shut down the robot and rebooted.Reentered into the case and once again, the foot pedals were connecting and the camera did not connect.They repeated all steps, checking the physical connections and rebooting the robot.It was, again, unsuccessful to connect to the camera and the surgeon was unable to use the robot for the case since it was not connecting to the camera.The procedure was completed, without delay, changing the surgical technique to manual instrumentation.Patient was not harmed as consequence of this problem.

Manufacturer Narrative

H3, h6: the navio camera cable, pn 200028, lot/sn unknown, 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 performed.The reported problem was confirmed.The cable was connected to the camera an into the system, and it did not work.The camera wasn't been recognize.The most likely cause is a failure or breakage in the internal wiring of the cable.The surgical technique guide provides a ¿recovery procedure guidelines¿ table that provides guidelines for recovering to a fully manual procedure.A review of manufacturing records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified 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.

• Brand Name: CABLE, CAMERA CART, NAVIO
• Type of Device: 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: 12526447
• MDR Text Key: 273129031
• Report Number: 3010266064-2021-00660
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 200028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: NPFS02000/NAVIO SURGICAL SYSTEM US
• Patient Outcome(s): Required Intervention