MAUDE Adverse Event Report: AMBU A/S ASCOPE 3 REGULAR; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number	403001000
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the defective device was not returned to the manufacturer and no lot number was available a simulation test was performed on a good sample.This simulation test confirmed that the reported problem - the distal tip of the bronchoscope being stuck in bend position - is most likely caused by excessive force being applied by the user to the control lever.The ascope 3 ifu states that the user should not exert excessive force to the control lever and bending section, as this may result in damage to the equipment.This mdr is resubmitted again as it was identified that original submission had not been successfully loaded into the fda database due to wrong file format.The initial mdr of this incident was submitted to the fda within the original reporting deadline.This submission represents a reload of data to ensure correct upload to the fda database.
Event or Problem Description
During an emergency bronchial fibroscopy in a (b)(6) year-old patient the distal end of the ascope 3 locked in a bent position.It was impossible to put it back in upright position.Patient outcome was not affected.However, the examination was interrupted because the ascope was difficult to direct.Extraction of the fiberscope from the intubation tube was complicated.There was a risk of extubation of the patient during the extraction of the fiberscope.No harm was caused to this patient, however, were this fault to recur it would pose a risk of causing serious injury.

• Brand Name: ASCOPE 3 REGULAR
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, dnk 2750 ; DA 2750
• MDR Report Key: 11998704
• Report Number: 1220828-2021-00001
• Device Sequence Number: 3782479
• Product Code: EOQ
• UDI-Device Identifier: 05707480121991
• UDI-Public: 05707480121991
• 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
• Type of Report: Initial
• Report Date (Section B): 01/07/2021

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: No Information
• Device Model Number: 403001000
• Device Catalogue Number: 403001000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1