MAUDE Adverse Event Report: AMBU A/S ASCOPE 4 BRONCHO; BRONCHOSCOPE

Lot Number 1000579091

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2022

Event Type  malfunction  

Event Description

The scope was used during a procedure.Upon extraction of the scope from a double lumen tube, the end of the scope started to unravel from the main body.The patient outcome was not affected due to the failure.

• Brand Name: ASCOPE 4 BRONCHO
• Type of Device: BRONCHOSCOPE
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, 2750 ; DA 2750
• Manufacturer Contact: joost venner ; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 15995496
• MDR Text Key: 308557491
• Report Number: 9610691-2022-00016
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 1000579091
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/18/2022
• Initial Date FDA Received: 12/16/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/02/2021
• 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