MAUDE Adverse Event Report: AMBU A/S ASCOPE 5 BRONCHO HD 5.0/2.2 SAMPLER SET

Catalog Number	621002000US
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We are unable to verify the reported failure (an obvious white piece of foreign body was noted inside the bronchus) as no returned sample was received for investigation, however we acknowledge this reported failure.To replicate the reported failure, a simulation was performed.Biopsy forceps (maximum od 1.9 mm) were repeatedly inserted into the working channel through the biopsy valve (without opening the biopsy valve cap).This is to replicate the failure observed by user.From the simulation test performed, it was observed that the failure mode was similar to the detailed description where the biopsy valve cap torn and detached after the tool was inserted multiple times (~15 times).The repeated insertions caused the torn area on the biopsy valve cap to gradually worsen, ultimately leading to detachment.According to the ifu, the biopsy valve cap can be detached by the user when necessary to facilitate tool insertion.The possible cause for the reported failure could be due to repeated tool insertions through the biopsy valve, which resulted in tearing of the white rubber component of the biopsy valve cap.The torn portion subsequently dislodged into the working channel and was observed falling into the bronchus during the procedure.No corrective action is required based on risk assessment.Ambu production perform 100% flow test inspection on each ascope to ensure the products is in good condition before shipment.Production, technical team and quality control have been aware of this feedback via quality alert and we will continue monitoring the market for similar incidents.
Event or Problem Description
Patient in for an outpatient bronchoscopy with washings, brushings, and possible biopsy under general anesthesia (with a lma [laryngeal mask airway]) due to left lower lobe infiltrates, consolidation, and mass.Procedure performed by dr.Pt was in the room by 0745, procedure started at 0757 after a pause at 0756.Procedure was going as planned, after two lavages and multiple washings due to mucous plugging, md stated he would like to get a brushing of left lower lobe.Writer opened brushing package, visual inspection of brush was completed, and brush was handed to dr.Md inserted brush into biopsy channel as usual, brush was observed coming out of biopsy channel at end of scope inside the bronchial, after md instructed writer to deploy brush out, brush was deployed, and upon brushing coming out of sheath cover, writer, dr, dr.Noticed something white to the left side of screen, next to brush.Once brush was retracted, and removed from biopsy channel, an obvious white piece of foreign body was noted inside the bronchus.Md attempted retrieval with a biopsy forcep, which failed, md noted that forcep was difficult to advance into biopsy channel, md did a visual inspection of the bronchoscope and asked for a new scope, md suspect foreign body may be a piece of the scope.With a new scope and an airway retrieval basket, foreign body was retrieved and was placed into a specimen cup.At this time, md named the foreign body an "iatrogenic foreign body".Brushing was completed and after more washing, procedure was competed at 0825.Pt was extubated and taken to pacu [post anesthesia recovery unit].Upon further inspection of bronchoscope by dr., a piece of plastic on the biopsy channel cap was noted to be missing, when compared to another intact biopsy channel cap.Foreign body appears to be "half-moon" shape, which matches missing piece of biopsy channel cap.Patient was not affected.Dr retrieved foreign body and competed procedure.

• Brand Name: ASCOPE 5 BRONCHO HD 5.0/2.2 SAMPLER SET
• Common Device Name: ASCOPE 5 BRONCHO HD 5.0/2.2 SAMPLER SET
• 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, mys 1900, ; MY 1900,
• Manufacturer Contact: catharina engelhardt ; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 23400282
• Report Number: 9610691-2025-00024
• Device Sequence Number: 10015936
• Product Code: EOQ
• UDI-Device Identifier: 05707480156511
• UDI-Public: 05707480156511
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K223782
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/28/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 621002000US
• Device Lot Number: 1001156886
• 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: 10/01/2025
• Initial Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2025
• 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