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

Model Number	N/A
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	07/24/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: FLEXIBLE VIDEO BRONCHOSCOPE, SINGLE USE
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 12406198
• Report Number: 9610691-2021-00014
• Device Sequence Number: 3391863
• Product Code: EOQ
• UDI-Device Identifier: 05707480135530
• UDI-Public: 05707480135530
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/26/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 478001000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention