MAUDE Adverse Event Report: AMBU A/S AMBU ASCOPE 4 BRONCHO REGULAR; FLEXIBLE VIDEO BRONCHOSCOPE

Model Number	477001000
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During a subacute bronchoscopy the bronchoscope got stuck in the tube and the distal part of the scope broke off and ended in the main bronchi and had to be retrieved.The scope was used with et tube 8.00 mm and was unable to move up and down.The tube was unaffected and had no traces of damage or deformity.The patient outcome was not affected.
Additional Manufacturer Narrative
The defective device has been discarded by the user.Lot number was not provided.The investigation was based on a photo provided by the user and a simulation performed on a sample to replicate the failure by using an et tube (id 7.5mm) to represent the tube used during the incident.The scope was inserted until the distal end came out of the et-tube.During removal the scope from the et-tube, the bending manipulator was activated caused by the bending section which was not in a straight (neutral) condition due to the scope stuck inside the tube.The excessive force to remove the scope with the distal end hooked outside the et-tube caused that the distal end of the scope was detached from the bending section.Conclusion based on the simulation test was that user had used excessive force to remove the ascope from the et tube causing the distal end to be detached from the bending section and left inside the main bronchi.The ifu has a warning information about withdrawal of ascope 4 broncho.The user should keep the distal tip in the neutral and non-deflected position.The user should not operate the control lever, as this may result in injury to the patient and/or damage to the endoscope.Further, according to the ifu for ascope 4 broncho family the user should always make sure that the bending section is in straight position (neutral/non-deflected) and excessive force should not be used when withdrawing the endoscope.The product risk evaluation has been evaluated and the risk is assessed as acceptable.No remedial, corrective or preventive actions are taken as a result of this event.Ambu will keep monitoring this issue and take actions if necessary.

• Brand Name: AMBU ASCOPE 4 BRONCHO REGULAR
• Common Device Name: FLEXIBLE VIDEO BRONCHOSCOPE
• 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: 13451175
• Report Number: 9610691-2022-00001
• Device Sequence Number: 4730773
• Product Code: EOQ
• UDI-Device Identifier: 05707480135509
• UDI-Public: 05707480135509
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K173727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2022

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: 477001000
• Device Catalogue Number: 477001000
• 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: 01/10/2022
• Initial Report FDA Received Date: 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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