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

Model Number	482001000
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During procedure when trying to get the wire through the balloon catheter the endoscopist experienced problems, a detachment between the outer part of handle and insertion tube was detected.The main tube was still connected.The procedure was immediately discontinued, and the malfunctioning scope was successfully removed and replaced with a new scope.Patient outcome was not affected.
Additional Manufacturer Narrative
The defective product has not been returned for investigation.However, a photo of the faulty device was provided by the customer from which ambu was able to verify the reported failure.Based on the preliminary complaint investigation the possible cause of main tube detachment was due a combination of failures where the torque force induced during procedure might lead to the joint became loose.Furthermore, it is likely that insufficient glue was applied while assembling the scope during production.Hence the likely root cause of the reported failure was a combination of weak gluing and excessive force applied to the device during procedure.Further investigation will be conducted to identify the actual cause of the failure after complaint sample is received.The device has not been received yet for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

• 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: 12750718
• Report Number: 9610691-2021-00016
• Device Sequence Number: 11689592
• Product Code: FDT
• UDI-Device Identifier: 05707480145287
• UDI-Public: 05707480145287
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 482001000
• Device Catalogue Number: 482001000
• Device Lot Number: 1000581517
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 11/04/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/27/2021
• 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
• Patient Sex: Unknown