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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 the case the system reverted back to the home screen.Were able to resume operation, re calibrate and pick up where it was left off.
 
Manufacturer Narrative
H10 h3, h6: the device was used in treatment and log files and case screenshots were returned for evaluation.It was reported that during the case, the system reverted back to the home screen the initial visual investigation of the log files found that: the error was a "segmentation fault" when the userre-entered the gap planning phase.This caused the system to unexpectedly exit the intraop portion ofnavio.The probable cause of the issue was a software failure.Dhr review found that the software version (rc- 5205) has been validated.A complaint history review found similar reports.A relationship between the device and the reported event could be established.
 
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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 Key9998178
MDR Text Key189489809
Report Number3010266064-2020-00809
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 07/30/2020
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 Received07/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age54 YR
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