MAUDE Adverse Event Report: AMBU A/S ASCOPE 3 REGULAR; BRONCHOSCOPE

Model Number	403001000
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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.
Event or Problem Description
During an emergency bronchial fibroscopy in a 10-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 interupted 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 reccur it would pose a risk of causing serious injury.

• Brand Name: ASCOPE 3 REGULAR
• Common Device Name: BRONCHOSCOPE
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 11130877
• Report Number: 9610691-2021-00001
• Device Sequence Number: 14348180
• Product Code: EOQ
• UDI-Device Identifier: 05707480121991
• UDI-Public: 05707480121991
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K161656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 01/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 10 YR