MAUDE Adverse Event Report: AMBU A/S ASCOPE 4 BRONCHO LARGE; FLEXIBLE VIDEO BRONCHOSCOPE, SINGLE-USE

Model Number 478001000

Device Problems Obstruction of Flow (2423); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/31/2021

Event Type  Injury  

Manufacturer Narrative

Ambu (b)(4) has received a report from a (b)(6) customer about an a scope 4 broncho from which the distal end broke off inside an intubation tube during use on a patient.The broken off part was removed from the patient along with the intubation tube and the patient was then successfully reintubated with a new intubation tube and bronchoscope.The user reported that they had used a size 7 mm intubation tube - this is the minimum applicable size dlt to be used with the ascope 4 broncho according to the ifu.Hence, usage of a too small intubation tube was ruled out.The user returned the intubation tube along with the broken off end.The broken off distal end was removed from the tube for further investigation.A simulation test was then performed using the returned intubation tube and a retention sample.The simulation test concluded that while a sufficiently lubricated ascope 4 broncho was able to be inserted and removed from the intubation tube with out any difficulties, when trying to remove a non-lubricated ascope 4 broncho from the intubation tube there was resistance.The scope did however not break during the simulation test.These results indicate that insufficient lubrication of the ascope 4 broncho by the user could have caused resistance, which might have lead to breakage of the device if excessive force was applied by the user during its removal.Visual investigation of the distal end indicated that there might have been some issues with the gluing process during production of the device.To sum up, the likely root cause of this issue is a combination of weak gluing of the distal end, insufficient lubrication before insertion and excessive force applied to the device when removing it.

Event Description

An ascope 4 boncho large was used on a patient with a size 7 intubation tube.The distal end of the broncoscope got stuck inside the tube and got detached.The intubation tube was completely obstructed.The distal end of the scope was removed with the size 7 intubation tube.Another ascope 4 broncho was used along with a size 8 intubation tube to intubate the patient.Patient outcome was not affected by the incident.

• Brand Name: ASCOPE 4 BRONCHO LARGE
• Type of Device: FLEXIBLE VIDEO BRONCHOSCOPE, SINGLE-USE
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, dnk 2750 ; DA 2750
• MDR Report Key: 12094716
• MDR Text Key: 259353493
• Report Number: 1220828-2021-00011
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/30/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2023
• Device Model Number: 478001000
• Device Catalogue Number: 478001000
• Device Lot Number: 1000430167
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention