MAUDE Adverse Event Report: TELEFLEX RUSCH GREENLITE; SINGLE-USE METAL LARYNGOSCOPE BLADE

Model Number MAC 3

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/19/2019

Event Type  Injury  

Event Description

During pre-op intubation by a student registered nurse anesthetist, the laryngoscope blade failed and broke.The base of the blade remained attached to the handle and the light remained on.When the blade broke it snapped the clear plastic fiber optic light source which flew into the air.The crna then removed the blade which remained in the pt's mouth checked for debris and proceeded to mask ventilate the pt while a glidescope was being obtained for intubation.In checking the broken device, it appeared a small clear plastic piece was missing.Linens and surrounding aea were thoroughly checked.Post operatively a chest x-ray was done, the fiber optic piece was determined to not be radiopaque.A ct was done, resulting in a radiopaque density measuring 8mm posterior basal right lower lobe.This was to be determined to be suspicious for a radiopaque foreign body.A bronchoscopy was done for potential foreign body retrieval.No foreign was retrieved from the bronch.The physician suspects the findings on the ct are not indicative of a foreign body given the size and location.During the investigation, it was reported a similar instance happened with a different provider, there was no pt harm, it was reported.

• Brand Name: RUSCH GREENLITE
• Type of Device: SINGLE-USE METAL LARYNGOSCOPE BLADE
• Manufacturer (Section D): TELEFLEX ; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 9142163
• MDR Text Key: 160888254
• Report Number: 9142163
• 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: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2024
• Device Model Number: MAC 3
• Device Catalogue Number: 004551003
• Device Lot Number: 1902331
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/24/2019
• Distributor Facility Aware Date: 09/19/2019
• Device Age: 7 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/25/2019
• 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: 51 YR
• Patient Weight: 91