MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NDI CAMERA POLARIS SPECTRA; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number PFSR200027

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 05/10/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during a navio preventative maintenance, the ndi camera polaris spectra had an intermittent camera error: camera infrared lamp is not working properly.No case involved; therefore, there was no patient involvement.

Manufacturer Narrative

H3, h6: the ndi camera polaris spectra, part number pfsr200027, (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 performed.The reported problem was confirmed.The camera was connected to a navio system and the infrared lamp failure error presented during case setup.The camera was connected to the ndi toolkit and the camera event log identified multiple infrared failures.The most likely cause is a failure of the internal infrared led board(s) of the camera.The camera is an oem product and cannot be disassembled further to arrive at a root cause.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.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: NDI CAMERA POLARIS SPECTRA
• 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: 14545175
• MDR Text Key: 292957220
• Report Number: 3010266064-2022-00421
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556649541
• UDI-Public: 885556649541
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PFSR200027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/01/2022
• 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: NAVIO SURGICAL SYSTEM AU, (B)(6)