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

Model Number PFSR200027

Device Problem Calibration Problem (2890)

Patient Problem No Patient Involvement (2645)

Event Date 12/19/2019

Event Type  malfunction  

Event Description

It was reported that in lab/demo camera infrared error popped up at calibration screen and did not read flat markers.No patient involved and procedure was cancelled.

Manufacturer Narrative

H10 h3, h6: the device, intended for use in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional evaluation could not be performed.A complaint history review found similar reports.There was no lot number, or part number noted in the initial investigation documents so we are unable to conduct a dhr review as a part of the investigation.It was not confirmed if the product met manufacturing specifications.A relationship, if any, between the subject device and the reported event could not be determined.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.A factor that could have contributed to the reported issue is if there was an issue with the illuminator leds on the camera.They can go bad over time and cause floating "dead zones" in the camera view.

• Brand Name: CAMERA, POLARIS SPECTRA
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 9990322
• MDR Text Key: 188654055
• Report Number: 3010266064-2020-01238
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: PFSR200027
• Device Catalogue Number: PFSR200027
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/09/2020
• Patient Sequence Number: 1