MAUDE Adverse Event Report: AMBU A/S AMBU ASCOPE 3 SLIM; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number CE 0086

Device Problems Break (1069); Detachment Of Device Component (1104); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/02/2017

Event Type  Injury  

Event Description

Ambu ascope 3 slim 3.8mm disposable flexible videoscope became stuck within the endotracheal tube airway during intubation of the patient.Two separate anesthesiologists attempted to remove the scope from the endotracheal tube.When they were finally able to remove the scope, they noted that the distal tip of the scope had broken off, and remained within the leumen of the endotracheal tube.This required the patient to be extubated to remove the broken portion of the scope and then reintubated with a new endotracheal tube.

• Brand Name: AMBU ASCOPE 3 SLIM
• Type of Device: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): AMBU A/S; MY
• MDR Report Key: 6791340
• MDR Text Key: 82682113
• Report Number: MW5071531
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/19/2018
• Device Model Number: CE 0086
• Device Catalogue Number: 4020001000
• Device Lot Number: 1999341
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR
• Patient Weight: 158