MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH TRULITE SECURE SINGLE-USE LARYNGOSCOPE HANDLE-BLADE COMBINATION ; LARYNGOSCOPE, RIGID

Model Number MILL 2

Device Problem Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Date 06/05/2020

Event Type  malfunction  

Event Description

Rusch trulite secure single-use laryngoscope handle-blade combination by teleflex was being used for intubation of patient prior to surgery.Once activated by the anesthesia provider, the end of the blade where the light source is located began to smoke.The anesthesia provider then deactivated the laryngoscope and it was not used on the patient.The ref# is 004670002, lot# 1909621, expiration: 09/15/2021.Fda safety report id# (b)(4).

• Brand Name: RUSCH TRULITE SECURE SINGLE-USE LARYNGOSCOPE HANDLE-BLADE COMBINATION
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL
• MDR Report Key: 10138000
• MDR Text Key: 194844840
• Report Number: MW5094921
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/15/2021
• Device Model Number: MILL 2
• Device Catalogue Number: 004670002
• Device Lot Number: 1909621
• 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