MAUDE Adverse Event Report: AMBU A/S ASCOPE 4 BRONCHO LARGE; FLEXIBLE VIDEO BRONCHOSCOPE, SINGLE-USE

Model Number	478001000
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	09/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The defective device has been received for investigation.Ambu was able to verify the reported failure (control lever had broken loose).Ambu investigated the defective sample and found that the control lever was loose due to a detached steering wire on the inside of the endoscope.With the wire detached, the endoscope won't function as intended and won't be able to bend the tip.Investigation of the defective sample and the retention sample from the same lot suggest that the wire has been detached due to excessive force on the lever.The wire was shown to have the specified diameter and the crimping was observed to be fully compressed on the defective device.Pull strength test were performed on both the defective device and the retention sample and both devices passed the test.As a conclusion, ambu has ruled out defective steering wire and improper crimping as cause of the defect.The complaint states that the defect was only detected after the device had been used.As a precheck is prescribed, it is evaluated that the fault occured as a result of the user applying excessive force due to having difficulties maneuvering the endoscope within a smaller space (eg.The et tube).This is characterised as rough handling in the product risk evaluation.It is evaluated in the product risk evaluation that breakage of the ascope 4 broncho due to rough handling by the user will not pose a serious risk of harm to the patient or user.The user is advised to have a suitable back up ready in case of a defective device.In this case two consecutive devices broke due to rough handling, and that is what lead to the hazardous situation and desaturation of the patient.
Event or Problem Description
During a fiberscopy in the icu the control lever of an ascope 4 broncho broke.The healthcare professionals immediately tried another ascope4 broncho from the same batch, but the control lever of that scope also broke.Due to the prolonged procedure, the patient desaturated.The endoscopy wsa then performed with a functional endoscope.Patient saturation level returned to normal.No long term serious health deterioration for the patient were reported.

• Brand Name: ASCOPE 4 BRONCHO LARGE
• Common Device Name: FLEXIBLE VIDEO BRONCHOSCOPE, SINGLE-USE
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup 2750, dnk, 2750 ; DA 2750
• MDR Report Key: 11940894
• Report Number: 1220828-2020-00009
• Device Sequence Number: 14456822
• Product Code: EOQ
• UDI-Device Identifier: 05707480135530
• UDI-Public: 05707480135530
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/15/2020

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: 06/04/2023
• Device Model Number: 478001000
• Device Catalogue Number: 478001000
• Device Lot Number: 1000397858
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/21/2020
• Device Age: 1 YR
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/04/2021
• 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