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U.S. Department of Health and Human Services

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

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BLUE BELT TECHNOLOGIES NDI CAMERA POLARIS SPECTRA ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
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.
 
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Brand NameNDI CAMERA POLARIS SPECTRA
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth, mn
Manufacturer (Section G)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth, mn
Manufacturer Contact
richard confer
2828 liberty ave
suite 100
pittsburgh, pa 
MDR Report Key10001063
MDR Text Key189085953
Report Number3010266064-2020-00172
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K191223
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberPFSR200027
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/29/2020
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 Reuse

Patient Treatment Data
Date Received: 04/27/2020 Patient Sequence Number: 1
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