MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH GREENLITE / SINGLE USE LARYNGOSCOPE BLADE; LARYNGOSCOPE RIGID

Model Number 004550001

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/05/2020

Event Type  malfunction  

Event Description

Light source of blade broke off during direct laryngoscopy, visualized in oropharynx and retrieved without difficulty.Fda safety report id# (b)(4).

• Brand Name: RUSCH GREENLITE / SINGLE USE LARYNGOSCOPE BLADE
• Type of Device: LARYNGOSCOPE RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL
• MDR Report Key: 10419590
• MDR Text Key: 203490735
• Report Number: MW5096092
• 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: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2023
• Device Model Number: 004550001
• Device Catalogue Number: IPN048379
• Device Lot Number: 1812411
• 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): Other
• Patient Age: 2 YR
• Patient Weight: 12