MAUDE Adverse Event Report: AMBU A/S ASCOPE 5 BRONCHO 2.7/1.2

Model Number	624001000US
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We were not able to verify the reported failure of the tool not being able to pass through working channel from the retention sample.There is a flow test performed on every ascope 5 broncho to verify that there is no blockage issue prior to shipment.Review of manufacturing records of the affected lot number showed that all scopes passed the flow test.The possible cause of the reported failure is suspected to be a friction between tool and working channel wall requiring high force to pass through the working channel.However, we were unable to comment further as no actual complaint sample was saved by the customer to be returned for investigation.Improvement of tool passage performance for ascope 5 broncho 2.7/1.2 has been implemented, however the lot number of reported failure was manufactured prior the action taken.Quality alert has been raised to production, quality control and industrial engineering team to increase their awareness on this market complaint.We will continue monitoring the market for similar complaints.
Event or Problem Description
It was reported by the customer that two ascope 5 broncho ultra-thin scope would not allow passage of erbe cryoprobe through working channel.During a routine cryo procedure with our a5 ultra-thin scope the staff had no problem passing the probe though the working channel until the end of the channel where resistance was felt, and the probe would not pass through the end of scope resulting in kinking the probe.The staff then switched to a new a5 ultra-thin scope from a different box with the same lot number as well as a new cryoprobe.The physician also removed the scope from the patient making sure the scope was completely straight and the problem still occurred again.After the second time the staff switched to a reusable olympus scope, and they had no problem passing the cryoprobe.The scopes came from two different boxes/ areas but had the same lot number.The procedure is categorized as off-label, since ascope 5 broncho was used on a pediatric patient.

• Brand Name: ASCOPE 5 BRONCHO 2.7/1.2
• Common Device Name: ASCOPE 5 BRONCHO 2.7/1.2
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, dnk 2750 ; DA 2750
• MDR Report Key: 20760784
• Report Number: 1220828-2024-00022
• Device Sequence Number: 9356289
• Product Code: EOQ
• UDI-Device Identifier: 05707480157280
• UDI-Public: 05707480157280
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2024
• Report Date (Section F): 10/28/2024

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: 624001000US
• Device Catalogue Number: 624001000US
• Device Lot Number: 1000982351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/23/2024
• Event Location: Hospital
• Date Report to Manufacturer: 10/28/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/22/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown