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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO SURGICAL SYSTEM INDIA ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES NAVIO SURGICAL SYSTEM INDIA ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number ROB00036
Device Problems Image Orientation Incorrect (1305); Intermittent Loss of Power (4016)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/09/2019
Event Type  malfunction  
Event Description
It was reported that in ukr case, while collecting the hip center, the system rebooted abruptly. After rebooting, during the handpiece calibration stage, the system was not picking up on the points as quickly as it does normally. Changed the flat markers to eliminate that possibility but still faced the same problem. Only proceeded after calibrating the handpiece by moving it very slowly. The lag between the actual position of the handpiece and on screen display persisted during the cutting stages as well. At this point the handpiece was swapped, but the issue was not resolved.
 
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Brand NameNAVIO SURGICAL SYSTEM INDIA
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth, mn
Manufacturer (Section G)
BLUE BELT TECHNOLOGIES
2828 liberty ave
suite 100
pittsburgh, pa
Manufacturer Contact
richard confer
2828 liberty ave
suite 100
pittsburgh, pa 
6833844
MDR Report Key9994246
MDR Text Key189308273
Report Number3010266064-2020-01103
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K191223
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 08/05/2020
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 NumberROB00036
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/28/2020
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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