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

Model Number	482001000
Health Effect - Clinical Codes	Abdominal Pain (1685); Perforation (2001)
Date of Event	03/24/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021, physician used ascope duodeno in a gi procedure.No medical device failure was noted for the duodenoscope during the procedure.On (b)(6) 2021, the patient came back with abdominal pain and during follow-up procedure a small perforation was found.No information available on which body structure part the perforation was.Patient outcome was not affected.
Additional Manufacturer Narrative
No sample was returned for investigation, nor was a lot number provided.It was not possible to verify the reported failure as no sample was available for investigation and there is lack of detailed information on the reported failure to assist in investigation.Possible cause of the perforation on the patient could be due to the device failure or insufflation pressure being too high.However, this was ruled out as the cause of the failure because physician didn't observe and note any failure on the complaint sample.Instruction for use is in place to alert the user, to ensure the top hole on insufflation valve is not blocked, to avoid over-insufflation and end up with patient perforation.

• Brand Name: AMBU ASCOPE DUODENO
• Common Device Name: ASCOPE DUODENO
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, denmark 2750 ; DA 2750
• MDR Report Key: 12887243
• Report Number: 1220828-2021-00019
• Device Sequence Number: 11103186
• Product Code: FDT
• UDI-Device Identifier: 05707480145287
• UDI-Public: 05707480145287
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/29/2021
• Report Date (Section F): 11/01/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/01/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/01/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/29/2021
• 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
• Patient Sex: Unknown