MAUDE Adverse Event Report: TELEFLEX MEDICAL GREEN RUSCHLITE; LARYNGOSCOPE, RIGID

Catalog Number 004551004

Device Problem Device Fell (4014)

Patient Problem Insufficient Information (4580)

Event Date 09/08/2021

Event Type  malfunction  

Event Description

The light source from the single use green ruschlite metal laryngoscope blade fell off the blade when attempting to use on a patient.It was able to be retrieved and there was no adverse patient outcome.Fda safety report id # (b)(4).

• Brand Name: GREEN RUSCHLITE
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL
• MDR Report Key: 12532559
• MDR Text Key: 273675735
• Report Number: MW5104202
• Device Sequence Number: 1
• Product Code: CCW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 004551004
• Device Lot Number: 2010341
• Was Device Available for Evaluation?: No
• 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): Other