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

Catalog Number 200027

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2019

Event Type  malfunction  

Event Description

It was reported that during a case, an error message for the infrared camera showed up during the registration process.The registration was very slow and the check point was off by 5.4 mm.The error was dismissed on screen and the case continued with no further issues.There was a short delay reported with no patient injury.The investigation found camera was showing the error "camera infrared lamp is not working properly" which is related to an illuminator hardware fault.

Manufacturer Narrative

H10 h3, h6: the device was used in treatment and the user received an error message for the infrared camera, during the registration process.It was also noted that the system was very slow.The camera was returned for investigation.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 initial investigation.After reviewing the log files, it was found that the error message that appeared is indicative of an illuminator hardware fault.The illuminator leds on the camera can go bad over time and they can cause floating dead zones in the camera view.The returned camera was connected to the ndi configure software - it was found that there was an illuminator hardware fault and that the camera needs to be returned for service.The camera was sent back to the oem for service.The malfunction is most probably due to supplier / raw material fault.

• Brand Name: CAMERA, POLARIS SPECTRA (CAMERA)
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth, mn
• MDR Report Key: 9994028
• MDR Text Key: 189734114
• Report Number: 3010266064-2020-00948
• 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: 04/23/2020

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: Health Professional
• Device Catalogue Number: 200027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Date Manufacturer Received: 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR