MAUDE Adverse Event Report: AMBU A/S ASCOPE 4 BRONCHO LARGE; FLEXIBLE VIDEO BRONCHOSCOPE, SINGLE USE

Model Number N/A

Device Problem Entrapment of Device (1212)

Patient Problem Cardiac Arrest (1762)

Event Date 07/24/2021

Event Type  Injury  

Manufacturer Narrative

No sample was returned for investigation, nor was a lot number provided.Therefore the test was performed on a retention sample and information provided by the user was used as input for the investigation.The user stated that the bronchoscope got stuck in the xlt distal tracheostomy disposable inner cannula during bronchoscopy.Based on the simulation results from a retention sample, the suspected cause of the reported failure could be due to insufficient lubricant applied on ascope when inserting the scope into the dlt.As prescribed in the ifu, the insertion cord should be lubricated with a medical grade lubricant before the endoscope is inserted into the patient.

Event Description

Ambu bronchoscope size large became stuck on xlt distal tracheostomy disposable innter cannula during bronchoscopy.It was reported that the bronchoscope got stuck during bronchoscopy on the inner cannula on xlt distal tracheostomy and the patient expired.During investigation, the nurse clarified that the bronchoscope did not cause the death of the patient, as the scope was successfully removed while the patient was alive.The nurse further clarified, that it was the patient's many other conditions that led to his unfortunate death.The device is therefore not related to the death of the patient.However, the incident did lead the patient to have an anxiety cardiac arrest.

• Brand Name: ASCOPE 4 BRONCHO LARGE
• Type of Device: FLEXIBLE VIDEO BRONCHOSCOPE, SINGLE USE
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, 2750 ; DA 2750
• Manufacturer (Section G): AMBU A/S; baltorpbakken 13; ballerup, 2750 ; DA 2750
• Manufacturer Contact: katrine ajbo ; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 12406198
• MDR Text Key: 269303349
• Report Number: 9610691-2021-00014
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 05707480135530
• UDI-Public: 05707480135530
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 478001000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention