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

Model Number	478001000
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ambu a/s has received a report from an germany customer about an ascope 4 broncho large from which the distal end broke off during use on a patient.The broken off part was succesfully removed from the patients lung by plumonologist on ermergency basis.Patient outcome was not affected.The defective product has not been returned for investigation due to contamination.Based on the investigation, the user reported that they that the patient was intubated with endotracheal tube size 7.5 mm - this is not an applicable size intubation tube for usage with the ascope 4 broncho large according to the ifu.According to the instruction for use (ifu) the minimum id (inner diameter) endotracheal tube size which can be used with ascope 4 broncho large is 7.0 mm.Hence, usage of a large intubation tube was ruled out and a wrong size of intubation tube can cause that the distal end of the scope can either get stuck or break off.In the complaint description provided by the user it was stated that upon pulling out the scope with great resistance, the distal end broke off.Based on the simulation test result, it was concluded that the distal end of the scope broke off when great resistance applied due to insuffucient lubricant or there is no further lubricant on the scope at the end of the procedure.According the product risk evaluation for the ascope 4 broncho, the likely cause of the resistance was that too little lubricant was applied to the endoscope before insertion.Hence the likely root cause of the reported failure was due to insufficient lubrication before insertion or there was no further lubricant on the scope at the end of the procedure.
Event or Problem Description
An ascope 4 broncho large was used on patient with a size 7.5 mm intubation tube.The distal end of the bronchoscope broke off during removal of the scope.The broken off piece had to be removed from the patients lung.Patient outcome was not affected by the incident as the piece was succesfully retrieved by the pulmonologists on an emergency basis.

• Brand Name: AMBU ASCOPE 4 BRONCHO LARGE
• 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: 15247249
• Report Number: 9610691-2022-00011
• Device Sequence Number: 5681739
• Product Code: EOQ
• UDI-Device Identifier: 05707480135530
• UDI-Public: 05707480135530
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/18/2022

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 Expiration Date: 09/30/2024
• Device Model Number: 478001000
• Device Catalogue Number: 478001000
• Device Lot Number: 1000591990
• 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: 07/28/2022
• Initial Report FDA Received Date: 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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