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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES HANDPIECE, NAVIO (BBT HANDPIECE), ROHS COMPLIANT ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES HANDPIECE, NAVIO (BBT HANDPIECE), ROHS COMPLIANT ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 110137
Device Problem Failure to Calibrate (2440)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/11/2018
Event Type  Injury  
Event Description
It was reported that, during set up for a case, the handpiece did not calibrate forcing an error to pop up. The system was rebooted per error and then integrity test error 40000000000 came up. Navio was aborted and case was completed with manual instruments. The patient outcome is unknown. The result of investigation indicate that the damaged cord caused a short circuit that blew a fuse in the siu, which is a reportable malfunction.
 
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Brand NameHANDPIECE, NAVIO (BBT HANDPIECE), ROHS COMPLIANT
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
2905 northwest blvd ste 40
plymouth, mn 
MDR Report Key9994102
MDR Text Key189345434
Report Number3010266064-2020-00756
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
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 08/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number110137
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/11/2020
Was Device Evaluated by Manufacturer? Yes
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: 04/23/2020 Patient Sequence Number: 1
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