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

Model Number	476001000
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/31/2021
Type of Reportable Event	Serious Injury
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.Using the principle when in doubt report, we have decided to report this incident.No specific event day was provided however, it is stated that the event occured during (b)(6) 2021.
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 risk is evaluated as acceptable, and this incident does not change this conclusion.Outcome: cause cannot be traced to ascope 4 broncho.

• Brand Name: ASCOPE 4 BRONCHO SLIM
• Common Device Name: FLEXIBLE BRONCHOSCOPE
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, 2750 ; DA 2750
• Manufacturer (Section G): AMBU A/S; baltorpbakken 13; ballerup 2750 ; DA 2750
• Manufacturer Contact: øzdemir ; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 13635822
• Report Number: 9610691-2022-00003
• Device Sequence Number: 11316019
• Product Code: EOQ
• UDI-Device Identifier: 05707480135479
• UDI-Public: 05707480135479
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K173727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown