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 tool not being able to pass through working channel from the retention sample.There is a flow test performed on every a scope 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.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 returned for investigation.Improvement of tool passage performance for a scope 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 thr customer that two scope 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 a scope 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, 2750 ; DA 2750
• Manufacturer (Section G): AMBU SDN. BHD.; lot 69-b, lintang; bayan lepas 6, phase iv; penang, 11900 ; MY 11900
• Manufacturer Contact: lenka vaculciakova ; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 20757475
• Report Number: 9610691-2024-00022
• Device Sequence Number: 9264159
• Product Code: EOQ
• UDI-Device Identifier: 05707480157280
• UDI-Public: 05707480157280
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K233671
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2024

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2024
• 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