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

Model Number	476001000
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/31/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Retention sample from same lot (lot no: 1000558399) has been retrieved for investigation as the original sample was not returned.Based on the investigation, no transparent plastic was found in the scope.It is suspected the transparent plastic come from the double lumen tube whereby the end of the tube was not cleanly cut and the scope was pushed further until the tiny plastic drop out from the tube and was left in the patient's airway.The identified transparent plastic is not relevant to the most similar material (bending cover) in ascope as the identified plastic is transparent, whereas the bending cover plastic is white color.Review on the packaging process of ascope 4 broncho indicates that the transparent plastic can't be from the pouch material as the tiny plastic identified is shaped as a ring and there is no tiny ring shape of plastic used for the packaging process.According to the ifu section 4.1 it is stated for the visual inspection of the product to check if there are no impurities on the product during preparation of ascope 4 broncho.Based on verification test performed, no transparent plastic was found in the scope.It is suspected the transparent plastic come from the double lumen tube whereby the end of the tube was not cleanly cut and the scope was pushed further until the tiny plastic drop out from the tube and was left in the patient's airway.The cause cannot be traced to ascope 4 broncho.
Event or Problem Description
A tiny rim of plastic which fits the rim and diameter of scope was found in the patient's airways and was retrieved from the lungs during the bronchoscopy.Left main bronchus tube was removed, a rigid and flexible bronchoscopy was performed and 4mm plastic was located and taken out using flexible biopsy forceps.The health care professional assumed that the plastic piece came from the tube of another device and entered the patients lungs.The patient was not harmed, but the procedure was significantly prolonged.No specific event day was provided however, it is stated that the event occured during (b)(6) 2021.

• Brand Name: ASCOPE 4 BRONCHO SLIM
• Common Device Name: FLEXIBLE BRONCHOSCOPE
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, dnk 2750 ; DA 2750
• MDR Report Key: 13654219
• Report Number: 1220828-2022-00004
• Device Sequence Number: 12212711
• Product Code: EOQ
• UDI-Device Identifier: 05707480135479
• UDI-Public: 05707480135479
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/02/2022

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 Model Number: 476001000
• Device Catalogue Number: 476001000
• Device Lot Number: 1000558399
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/02/2022
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2022
• 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
• Patient Sex: Unknown