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

Catalog Number PFSR200027

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/15/2015

Event Type  Injury  

Event Description

It was reported that during setup, handpiece/equipment was assembled as normal, plugged in and began calibration.After a couple of failed attempts at calibration, we took the point probe off and snapped it back into place.That did not work.We tried switching out the tracking array, switching out the handpiece, made sure the probe was parallel with the handpiece and placed pressure on the two to keep them together.We tried putting 4x4 gauze in between the probe and the hand piece to hopefully tighten up the wiggle room between the two, we switched out the 5 mm guard for a 6 mm guard.We noticed that the light coming in from the window could be an issue so we put blankets over the windows, tried facing the camera and spheres away from the windows, turned off the lights in the room.We shutdown the system and rebooted a couple of times and that did not work.We ran out of things to try and called a navio specialist for assistance and still could not get any of the hand pieces to calibrate.The handpieces from trays one and two were taken to try to calibrate them while in the room and still could not get it to pass.The procedure had to convert to manual.Investigation at the site showed that the camera lens was dirty due to incorrect cleaning.The lens was cleaned and all functionality was restored.

Manufacturer Narrative

H10: the device was intended for use in treatment and case log files and screenshots were returned for review.There was no serial or lot number provided for dhr review so it could not be concluded if the device met the manufacturing specifications.A complaint history found similar reports, this issue will continue to be monitored.The surgical system user's manual released at the time of the complaint (pn 500054 rev g) provides solution for the described camera error.This is an identified failure mode within the risk assessment.The investigation confirmed there was a relationship established between the reported event and the device.A review of the log files indicated a sampling error during nearly all of the calibration attempts.This can be caused by a number of events: reflective surface in the field of view; another tracker overlapping the intended calibration; dirty/damaged spheres; damaged/obscured camera lens; lighting issues on the trackers; and/or movement between the probe and handpiece during calibration.During a site visit, the service manager, was able to determine that the cleaning wipes used over the camera lenses was causing residues to be left on the lens.The malfunction is most probably due to recommended maintenance not performed.Per complaint details, the device malfunctioned during use and the navio was abandoned for manual instrumentation.Based on the information provided the modified procedure did not result in patient injury/impact; therefore, no further medical assessment is warranted at this time.

• 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
• MDR Report Key: 10001063
• MDR Text Key: 189085953
• Report Number: 3010266064-2020-00172
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PFSR200027
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/15/2015
• Initial Date FDA Received: 04/27/2020
• Supplement Dates Manufacturer Received: 07/29/2020
• Supplement Dates FDA Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention