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

Model Number	477001000
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The defective device has not been returned for investigation.Neither sample nor lot number were available, therefore it has not been possible to retrieve a retention sample for investigation.Hence, it is not possible to verify the reported failure.Based on user feedback, the endoscope broke due to human error because ascope4 broncho regular was chosen by mistake instead of ascope4 broncho slim.Since there is no further information on the ett size used during procedure, it is suspected that the scope size was not compatible with the used et tube.Instructions for use (ifu) section 2.2 product compatibility informs which sizes of the ascope 4 broncho family is compatible with the different et tubes.The product risk evaluation has been evaluated and the risk is assessed as acceptable.Ambu will keep monitoring this issue and take actions if necessary.
Event or Problem Description
An ascope 4 broncho regular bronchoscope was used instead of the slim.During use, the tip of the bronchoscope was teared inside the patient's tubus.The customer noted that this happened due to improper use (not according to the manufacturer's instructions).Patient outcome was not affected.

• Brand Name: 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: 14952832
• Report Number: 9610691-2022-00009
• Device Sequence Number: 6944859
• Product Code: EOQ
• UDI-Device Identifier: 05707480135509
• UDI-Public: 05707480135509
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K173727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/07/2022

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: 06/16/2022
• Initial Report FDA Received Date: 07/08/2022
• 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
• Patient Sex: Unknown