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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES SIU - SOFTWARE INTERFACE UNIT ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES SIU - SOFTWARE INTERFACE UNIT ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 220025
Device Problem Electrical Shorting (2926)
Patient Problem No Patient Involvement (2645)
Event Date 03/05/2019
Event Type  malfunction  
Event Description
It was reported that navio surgical system continuously displays hardware error message (errcode
=
40000000000) during demo. Inspected the unit and found that the siu was not functioning according to specification. Demo was completed as a manual procedure.
 
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Brand NameSIU - SOFTWARE INTERFACE UNIT
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2828 liberty ave
suite 100
pittsburgh, pa
Manufacturer (Section G)
BLUE BELT TECHNOLOGIES
2828 liberty ave
suite 100
pittsburgh, pa
Manufacturer Contact
richard confer
2828 liberty ave
suite 100
pittsburgh, pa 
6833844410
MDR Report Key9998664
MDR Text Key189503126
Report Number3010266064-2020-01068
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
K191223
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/10/2020
1 Device was Involved in the Event
0 Patients were 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
Device Catalogue Number220025
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/02/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/03/2020
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

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