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

MAUDE Adverse Event Report: TELEFLEX RUSCH GREEN LITE

  • 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
 

TELEFLEX RUSCH GREEN LITE Back to Search Results
Model Number MILLER 2
Device Problems Break (1069); Detachment Of Device Component (1104); Device Operates Differently Than Expected (2913)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/08/2017
Event Type  Injury  
Event Description
Our quality improvement committee received two separate reports of the rusch green life miller #2 or #3 blade's light pipe breaking off the blade with normal use. Luckily the broken piece was recovered from patient's mouth during intubation. Also, the light source occasionally does not work intermittently during laryngoscopy. I have evaluated the blades myself and the mac blade's light pipe seems well seated in the blade, but the miller blade's light pipe does have potential to slip out of the blade and break off with moderate force.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameRUSCH GREEN LITE
Type of DeviceRUSCH GREEN LITE
Manufacturer (Section D)
TELEFLEX
3015 carrington mill blvd.
NC 27560
MDR Report Key6399040
MDR Text Key69963381
Report NumberMW5068401
Device Sequence Number1
Product Code EQH
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 03/09/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received03/09/2017
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMILLER 2
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/09/2017 Patient Sequence Number: 1
-
-