• 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 ROBOTICS INSTR; 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 ROBOTICS INSTR; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number NPFS02000
Device Problems Connection Problem (2900); No Apparent Adverse Event (3189)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/28/2020
Event Type  malfunction  
Event Description
It was reported that during preventive maintenance, while changing the ups battery there was an issue with the battery connector.No patient was involved.No other complications were reported.
 
Manufacturer Narrative
G3, h2, h3, and h6: the navio surgical system (us) ups battery, product 200029, lot 2531avhsm875900201, intended for use in treatment was returned for evaluation.A relationship between the reported event and the device was confirmed.The reported problem was visually confirmed.The minus terminal was damaged during the battery replacement process.A functional evaluation could not be performed due to broken/damaged parts.The battery terminal is permanently damaged.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.The most likely cause of this event is improper handling of the part.The battery leads arced removing metal from the terminal when the service tech was inserting the battery into the ups.Refer to the product service instructions that provide guidelines for replacing the battery.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.D4, d8, d9 and h5: device returned.D10: add concomitants.G1: address updated.G4: add 510k code.H6: code update.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NAVIO ROBOTICS INSTR
Type of Device
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest blvd
suite 40
plymouth, mn
MDR Report Key10203845
MDR Text Key196930091
Report Number3010266064-2020-01608
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
PMA/PMN Number
K152574
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 08/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberNPFS02000
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/18/2020
Initial Date Manufacturer Received 05/28/2020
Initial Date FDA Received06/26/2020
Supplement Dates Manufacturer Received08/27/2021
Supplement Dates FDA Received08/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNKN NAVIO ROBOTICS INSTR/UNK
-
-