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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 Misassembly by Users (3133)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/17/2021
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference case-(b)(4).
 
Event Description
It was reported that, during set up for a navio assisted pfa, they plugged the navio surgical system us without the monitor plugged in and could not get navio screens turned on. ¿no signal detected¿ error screens populated on the monitor after 1 beep and then 4 additional beeps. They did a shut down and restart, same issue. They tried using a different outlet for the power cord, and had the same issue. They tried unplugging the plug inside the navio connected to the fuse box and plugging it into the wall outlet, and had same issue. They contacted robotics support and tried every option possible, and still having the same issue. The procedure was completed with manual instrumentation without significant delays. The patient was not harmed beyond the reported problem. After the case, they plugged the navio into the hallway outlet and somehow, the navio started working.
 
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Brand NameNAVIO SURGICAL SYSTEM US
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth MN 55441
Manufacturer (Section G)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth MN 55441
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key12964471
MDR Text Key283158215
Report Number3010266064-2021-00849
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 Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNPFS02000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/17/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/08/2021 Patient Sequence Number: 1
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