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

Model Number	477001000
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The tip of an ambu ascope 4 broncho regular broke off inside the endotracheal airway tube of a patient.The physician used another scope to confirm that nothing was lodged in the patient.Patient outcome was not affected.
Additional Manufacturer Narrative
The defective device has been disposed by the user.Lot number was not provided.A simulation test was 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 bending level was set to the maximum to have the bending section in complete bend condition and then be able to withdraw it from et tube.We observed that the bending section would not go in the et tube condition due to the bending section was overbent and stuck in et tube.According to the instruction for use (ifu), section 1,4 warning and cautions, states that inappropriate handling in operation bending section inside ett where resistance felt may result damage to the equipment.Based on the product risk evaluation it is stated that the user who handles the scope roughly, operating the bending section with force inside a smaller space will cause parts of the bending mechanism to break.When the distal end of the scope brakes, there is a risk of injury and exposure of non-contacting material to the patient.This could result in damage or impairment and requires to be counteracted by professional medical intervention as evidenced.

• 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: menekse øzdemir ; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 14347583
• Report Number: 9610691-2022-00006
• Device Sequence Number: 17182463
• Product Code: EOQ
• UDI-Device Identifier: 05707480135509
• UDI-Public: 05707480135509
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 04/13/2022
• Initial Report FDA Received Date: 05/10/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown