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

Model Number	478001000
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ambu a/s has received a report from an us customer about an ascope 4 broncho from which the distal end broke off during use on a patient.The broken off part was successfully removed from the patient's airways.Patient outcome was not affected.The defective product has not been returned for investigation.However, a photo of the faulty device was provided by the customer from which ambu was able to verify the reported failure.The user reported that they had used a size 8 mm intubation tube - this is an applicable size intubation tube for usage with the ascope 4 broncho according to the ifu.Hence, usage of a too small intubation tube was ruled out.In the complaint description provided by the user it was stated that the scope got stuck during removal.Upon pulling on the scope, the distal end broke off.Based on the product risk evaluation for the ascope 4 broncho, the likely cause of the resistance was that too little lubricant was applied to the endoscope before insertion.Furthermore, it is likely that insufficient glue was applied while assembling the scope during production.Hence the likely root cause of the reported failure was a combination of weak gluing of the distal end, insufficient lubrication before insertion and excessive force applied to the device when removing it.
Event or Problem Description
An ascope 4 boncho large was used on a patient with a size 8 intubation tube.The distal end of the bronchoscope broke off during removal of the scope.The broken off piece had to be removed from the patient's airways.Patient outcome was not affected by this incident as the piece was successfully retrieved at bedside.

• Brand Name: AMBU ASCOPE 4 BORNCHO LARGE
• Common Device Name: FLEXIBLE VIDEO BRONCHOSCOPE,
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 12222996
• Report Number: 9610691-2021-00013
• Device Sequence Number: 5002794
• 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,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/22/2021

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 Expiration Date: 09/02/2023
• Device Model Number: 478001000
• Device Catalogue Number: 478001000
• Device Lot Number: 1000487773
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2021
• Initial Report FDA Received Date: 07/25/2021
• 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