MAUDE Adverse Event Report: AMBU A/S ASCOPE 4 BRONCHO; ASCOPE 4 BRONCHO REGULAR

Model Number	477001000
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Distal tip detached from the bronchoscope during procedure.The scope was removed from the patient immediately.Patient outcome not affected.
Additional Manufacturer Narrative
Scope not received for investigation yet.Picture of scope provided.Fault verified from picture.Scope retrieved for investigation from retention sample.The tip of the retention sample was verified being in good condition.Simulation test was performed on retention sample to replicate reported failure.An ett size 6.00mm and a dlt size 41fr.Was used being the minimum compatible sizes.The retention sample was lubricated and passed through the tubes smoothly.The test was then repeated with smaller sized tubes (ett 5.0mm and dlt 37fr.).The scope was stuck in the entry of the ett and could not pass.In the dlt the scope got stuck during insertion and after removal the tip was observed broken.No feedback was received from customer on the size of tube being used.Compatible sizes ett and dlt are indicated in the ifu.Based on available information and the performed simulation test it is suspected that scope got stuck in a tube with a non-compatible size (being to small) and removed with excessive force thereby causing the tip of the scope to break.According to ifu the user shall not apply excessive force, when removing the endoscope.

• Brand Name: ASCOPE 4 BRONCHO
• Common Device Name: ASCOPE 4 BRONCHO REGULAR
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup 2750 ; DA 2750
• Manufacturer (Section G): NAME AND ADDRESS: AMBU SDN. BHD.; lintang bayan lepas, phase iv; lot 69-b; penanag, 11900 ; MY 11900
• Manufacturer Contact: kristine rasmussen ; baltorpbakken 13; ballerup 2750 ; DA 2750
• MDR Report Key: 16395800
• Report Number: 9610691-2023-00008
• Device Sequence Number: 6384739
• Product Code: EOQ
• UDI-Device Identifier: 05707480135509
• UDI-Public: 05707480135509
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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): 02/17/2023

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: 477001000
• Device Catalogue Number: 477001000
• Device Lot Number: 1000591972
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2023
• Initial Report FDA Received Date: 02/17/2023
• 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: Other
• Patient Sex: Unknown