MAUDE Adverse Event Report: TELEFLEX RUSCH GREEN LITE

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.

• Brand Name: RUSCH GREEN LITE
• Type of Device: RUSCH GREEN LITE
• Manufacturer (Section D): TELEFLEX; 3015 carrington mill blvd.; NC 27560
• MDR Report Key: 6399040
• MDR Text Key: 69963381
• Report Number: MW5068401
• Device Sequence Number: 1
• Product Code: EQH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• 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 Received: 03/09/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MILLER 2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 70