MAUDE Adverse Event Report: AMBU A/S ASCOPE SLIM; BRONCHOSCOPE

Catalog Number	402001000
Health Effect - Clinical Codes	Extubate (2402); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported failure was verified on the returned sample.Bending section was teared into 2 sections.The hinge of the returned sample was broken at bending point.The cause of the reported failure is suspected to be due to bending section not being in neutral (straight) condition when withdrawn through the tube.The scope can hereby get stuck in the tube.The hinge being broken at bending point support the suspected cause of the reported failure.According to ifu; while withdrawing the ascope 3, the distal tip must be in neutral and non-deflected position.Do not operate the bending lever, at this may result in injury to the patient and/or damage the ascope 3".It is therefore suspected that the cause of the reported failure is due to use error, not having the bending section in a neutral position when withdrawing.
Event or Problem Description
Ascope 3s was used in a video-assisted intubation procedure for placement of a 37fr double lumen tube.Once the dlt was placed in the patient's airway the anesthesiologist was unable to withdraw the scope from the lumen of the dlt.The scope was stuck in the tube and was removed with significant force.When the scope was from the dlt, the anesthesiologist noticed that the distal end of the scope had broken of and the broken part was still in the lumen of the dlt.A second ascope was used to confirm the placement of the distal tip within the lumen of the dlt.To solve the situation, the dlt was withdrawn from the patient and patient was re-intubated with a new tube.

• Brand Name: ASCOPE SLIM
• Common Device Name: BRONCHOSCOPE
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, dk 2750 ; DA 2750
• MDR Report Key: 6852181
• Report Number: 9610691-2017-00007
• Device Sequence Number: 13810673
• Product Code: EOQ
• UDI-Device Identifier: 05707480121960
• UDI-Public: 5707480121960
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: 161656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2017
• Report Date (Section F): 08/10/2017

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 402001000
• Device Lot Number: 1999341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2017
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/10/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/10/2017
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2017
• Initial Report FDA Received Date: 09/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention