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

Catalog Number 200027

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2018

Event Type  malfunction  

Event Description

It was reported that before a tka case, the orange light on the camera turned on and was displaying an error on the screen.There was a delay in the procedure while equipment was swapped.No patient injury was reported.The investigation confirmed there was a problem with the led illuminator.

Manufacturer Narrative

H10: h3, h6: the device was intended for use in treatment and was returned for investigation.The user found that the yellow light on the camera recently turned on and was displaying an error on the screen.Dhr review found that no conditions which could contribute to the reported event were identified.This information is reasonably suggesting that the device met the specifications at the date when it was released to the distribution.A complaint history found similar reports, this issue will continue to be monitored.The investigation confirmed there was a relationship established between the reported event and the device.The device was returned and investigated for the initial investigation.The returned camera was connected to the system and there was an error saying that the "camera infrared lamp is not working properly" and the orange light on the camera turned on.The illuminator leds on the camera can go bad over time and they can cause floating dead zones in the camera view.The warning message is displayed when the system detects the error from the camera.The malfunction is most probably due to supplier / raw material fault.No containment or corrective actions are recommended at this time.

• Brand Name: CAMERA, POLARIS SPECTRA
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth, mn
• MDR Report Key: 9998629
• MDR Text Key: 189579628
• Report Number: 3010266064-2020-00565
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/24/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 200027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2018
• Initial Date Manufacturer Received: 08/27/2018
• Initial Date FDA Received: 04/24/2020
• Supplement Dates Manufacturer Received: 06/18/2020
• Supplement Dates FDA Received: 06/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1