MAUDE Adverse Event Report: AMBU A/S AMBU DISPOSABLE BRONCHOSCOPE; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Device Problem Entrapment of Device (1212)

Patient Problem Insufficient Information (4580)

Event Date 07/24/2021

Event Type  Death  

Event Description

Ambu bronchoscope size large became stuck on 8shiley xlt distal tracheostomy disposable inner cannula during bronchoscopy.

• Brand Name: AMBU DISPOSABLE BRONCHOSCOPE
• Type of Device: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): AMBU A/S ; 6230 old dobbin lane; ste 250; columbia MD 21045
• MDR Report Key: 12245188
• MDR Text Key: 264267606
• Report Number: MW5102825
• Device Sequence Number: 1
• Product Code: EOQ
• 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: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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): Death
• Patient Age: 67 YR
• Patient Weight: 121