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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 Problem Intermittent Communication Failure (4038)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/12/2021
Event Type  Injury  
Event Description
It was reported that during machine setup before a navio procedure, it was found that the anspach footpedal is showing disconnected on the hardware setup screen. The connection was reset and the machine was rebooted - still the problem persisted. The surgery was done manually with conventional smith and nephew instrument set. No other complications were reported.
 
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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 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 Key11617631
MDR Text Key243903274
Report Number3010266064-2021-00263
Device Sequence Number1
Product Code OLO
UDI-Device Identifier00885556693506
UDI-Public885556693506
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
EXEMPT
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,Followup,Followup
Report Date 02/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberROB00036
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/06/2021 Patient Sequence Number: 1
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