MAUDE Adverse Event Report: AMBU A/S AMBU ASCOPE DUODENO; DUODENOSCOPE

Model Number	482001000
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Ulcer (2274); Heart Failure/Congestive Heart Failure (4446); Swelling/ Edema (4577)
Date of Event	11/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The defective product has not been returned for investigation and it was therefore not possible to verify the reported failure.As the defective product was not returned a retention sample was used to simulate the reported failure.The stent was stuck at the distal tip during bending at 90°, however the stent was able to move out from the distal end without any issue when changing the angle of distal end 0°.Based on the test results, the reported issue of the stent being stuck in the endoscope at the elevator area, is suspected to be due to angulation of the bending section or the angulation of the elevator on the scope during insertion/withdrawal of the stent.The accompanying ifu states that the user shall ensure to straighten the bending section as much as possible when inserting / withdrawing an endoscopic accessory.The product risk evaluation has been evaluated and the risk is assessed as acceptable.Ambu will continue to monitor the issue of endoscopic tool passage failure.
Event or Problem Description
Ercp was performed on an elderly patient with an active bleeding ulcer and bilateral under extremity edema and, which is a symptom for a wide range of medical conditions including chronic heart failure.During the procedure the physician had difficulty exiting the stent through the distal end of the working channel.The physician tried three unsuccessful consecutively times to deliver the stent and during this the wire was released from the elevator which contributed to a prolonged procedure.During this prolonged procedure the patient had a cardiac failure.The malfunctioning scope was removed, and a new scope was used to install the stent and stabilize the patient.After the procedure the patient was referred to the icu.

• Brand Name: AMBU ASCOPE DUODENO
• Common Device Name: DUODENOSCOPE
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, dnk 2750 ; DA 2750
• MDR Report Key: 12918119
• Report Number: 1220828-2021-00020
• Device Sequence Number: 14864240
• Product Code: FDT
• UDI-Device Identifier: 05707480145287
• UDI-Public: 05707480145287
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2021

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: 482001000
• Device Catalogue Number: 482001000
• Device Lot Number: 1000581523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/05/2021
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/02/2021
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown