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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO SURGICAL SYSTEM US; ORTHOPEDIC STEREOTAXIC INSTRUMENT
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BLUE BELT TECHNOLOGIES NAVIO SURGICAL SYSTEM US; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number NPFS02000
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/16/2018
Event Type  malfunction  
Event Description
It was reported that during case the system reverted back to the home screen during the case.Hit resume operation, re-calibrated and picked up where it was left off.
 
Manufacturer Narrative
H10 h3, h6: the device was used in treatment when the navio software unexpectedly exited out of the case.Case log files were returned for evaluation.Dhr review found that the software version (navio rc-5205) has been validated.A complaint history review identified similar events.We could confirm there was a relationship established between the reported event and the device.Review of the log files confirmed the exit occurred while in the planning phase of a ukr procedure.The malfunction was due to a software failure and this issue is being investigated by the software engineering team.
 
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Brand Name
NAVIO SURGICAL SYSTEM US
Type of Device
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth, mn
MDR Report Key9998189
MDR Text Key189451242
Report Number3010266064-2020-00810
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
PMA/PMN Number
K191223
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 07/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberNPFS02000
Was Device Available for Evaluation? Yes
Date Manufacturer Received07/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age80 YR
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