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

Model Number	476001000
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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to break off.According to the product ifu, the distal tip must be set in a neutral or non-deflected position when being withdrawn and excessive force should be avoided when using the product: do not use excessive force when advancing, operating or withdrawing the ascope 4 broncho.When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.This mdr is resubmitted again as it was identified that original submission had not been successfully loaded into the fda database due to wrong file format.The initial mdr of this incident was submitted to the fda within the original reporting deadline.This submission represents a reload of data to ensure correct upload to the fda database.
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, dnk 2750 ; DA 2750
• MDR Report Key: 11940882
• Report Number: 1220828-2020-00010
• Device Sequence Number: 4015541
• Product Code: EOQ
• UDI-Device Identifier: 05707480135479
• UDI-Public: 05707480135479
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/14/2020
• Report Date (Section F): 11/15/2020

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: 01/07/2023
• Device Model Number: 476001000
• Device Catalogue Number: 476001000
• Device Lot Number: 1000410944
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/15/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/15/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/04/2021
• 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