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

Model Number	482001000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Perforation (2001)
Date of Event	03/24/2021
Type of Reportable Event	Serious Injury
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 patient could be due to device failure / insufflation pressure 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.
Event or Problem Description
On (b)(6) 2021 physician used scope duodeno in a gi procedure.No medical devices 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.

• Brand Name: AMBU ASCOPE DUODENO
• Common Device Name: ASCOPE DUODENO
• 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: lena søndergaard ; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 12880680
• Report Number: 9610691-2021-00017
• Device Sequence Number: 3948472
• Product Code: FDT
• UDI-Device Identifier: 05707480145287
• UDI-Public: 05707480145287
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K201098
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/30/2021

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2021
• Initial Report FDA Received Date: 11/29/2021
• 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