• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO INSTRUMENT TRAY ORTHOPEDIC STEREOTAXIC INSTRUMENT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BLUE BELT TECHNOLOGIES NAVIO INSTRUMENT TRAY ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number PFSR101098
Device Problems Tear, Rip or Hole in Device Packaging (2385); Contamination /Decontamination Problem (2895)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/02/2014
Event Type  malfunction  
Event Description
It was reported that during the setup, the scrub nurse checked the wrapping for the sterilised navio tray. It had a small hole in it. Therefore, this tray was not able to be used. They opened the sterile wrap for the second tray and found the same, a small hole. Obviously the wrapping had been removed from the tray but the position looked like it would correspond to the corner of the navio tray. The case could not proceed using the navio system. Proceeded to manual.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNAVIO INSTRUMENT TRAY
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
2828 liberty ave
suite 100
pittsburgh, pa 
MDR Report Key9994422
MDR Text Key188804864
Report Number3010266064-2020-00158
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K191223
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberPFSR101098
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/06/2020
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 Reuse

Patient Treatment Data
Date Received: 04/24/2020 Patient Sequence Number: 1
-
-