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

Model Number	476001000
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The defective device has not been returned for investigation.Verification was done on a retention sample by inserting a sufficient lubricated insertion cord into a 37 fr double lumen tube.The lubricated insertion cord is able to move smoothly within the intubation tube, hence it is not possible to verify the reported failure from the retention sample.Investigation on the fractured of the tip inside dlt is still in progress.From the preliminary investigation result, it is suspected that user was not aware of that the tip of the main tube was inside dlt which led to user's impression that the tip extender was jammed.However, a jammed tip extender will not lead to fracture of the main tube.The ifu has a warning information about withdrawal of ascope 4 broncho.The user should keep the distal tip in the neutral and non-deflected position.The user should not operate the control lever, as this may result in injury to the patient and/or damage to the endoscope.Further, according to the ifu for ascope 4 broncho family the user should always make sure that the bending section is in straight position (neutral/non-deflected) and excessive force should not be used when withdrawing the endoscope.Ambu will keep monitoring this issue and take actions if necessary.
Event or Problem Description
The date of the event has not been reported.Jamming of the tip extender resulting in fracture of tip within the endotracheal tube.The thumb operated tip flexor/extender became jammed in hyper acute flexion position.It was impossible to extract the scope conventionally.When a little firm pressure was applied to extract the scope the device fractured at the level of the tip, with the tip remaining at the bifurcation of the endotracheal tube.The entire tip was removed at the end of the case intact after extubation.The patient was unharmed but the double lumen tube was compromised and an additional uneventful bronchoscopy was performed at the end of the case to verify that there was no foreign body in the distal bronchi.Patient outcome not affected.

• Brand Name: ASCOPE 4 BRONCHO SLIM
• 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: lena søndergaard ; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 14927574
• Report Number: 9610691-2022-00008
• Device Sequence Number: 12313056
• Product Code: EOQ
• UDI-Device Identifier: 05707480135479
• UDI-Public: 05707480135479
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 07/06/2022

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: 476001000
• Device Catalogue Number: 476001000
• Device Lot Number: 1000568014
• 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: 06/11/2022
• Initial Report FDA Received Date: 07/06/2022
• 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
• Patient Sex: Unknown