MAUDE Adverse Event Report: TELEFLEX MEDICAL; LARYNGOSCOPE, RIGID

Model Number IPNO48380

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 09/23/2019

Event Type  malfunction  

Event Description

During intubation it was noted by the anesthesia provider that a small plastic piece had broken off the laryngoscope blade and was visualized in the back of the throat.Multiple attempts to locate and retrieve it were made by the anesthesia provider, the anesthesiologist in charge, a pulmonary doctor, and a general surgeon.The broken piece was located and retrieved by the general surgeon.

• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 9179628
• MDR Text Key: 161985505
• Report Number: 9179628
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/24/2019,09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPNO48380
• Device Catalogue Number: 004550002
• Device Lot Number: 1904421
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/24/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24455 DA