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

Model Number	476001000
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No sample was returned for investigation and so ambu has not been able to verify the failure.The expected cause of the reported failure is mis-handling where the bending section was not in straight (neutral) position during extraction of the bronchoscope from the dlt and excessive force was applied to pull out the ascope.This caused the distal end of the ascope to break off.According to product ifu, the distal tip must be set in a neutral or non-deflected position when being withdrawn and excessive force should be avoided when using the product: do not use excessive force when advancing, operating or withdrawing the ascope 4 broncho.When withdrawing the endoscope, the distal tip must be in neutral and non-deflected position.Do not operate the bending lever, as this may result in injury to the patient and/or damage to the ascope 4 broncho.The reported problem is included in the product risk analysis.
Event or Problem Description
The tip of an ambu ascope 4 broncho slim 3.8/1.2 single-use and flexible bronchoscope broke off inside the endotracheal airway tube of a patient.The broken off piece was retrieved by the physician.Patient outcome was not affected.

• Brand Name: ASCOPE 4 BRONCHO SLIM
• Common Device Name: FLEXIBLE VIDEO BRONCHOSCOPE, SINGLE-USE
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 11848431
• Report Number: 9610691-2020-00010
• Device Sequence Number: 14414566
• Product Code: EOQ
• UDI-Device Identifier: 05707480135479
• UDI-Public: 05707480135479
• 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: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/11/2020

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 Expiration Date: 07/01/2023
• Device Model Number: 476001000
• Device Catalogue Number: 476001000
• Device Lot Number: 1000410944
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2020
• Initial Report FDA Received Date: 05/19/2021
• 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