MAUDE Adverse Event Report: AMBU A/S AMBU ASCOPE 3 SLIM; BRONCHOSCOPE

Catalog Number 402001000

Device Problems Entrapment of Device (1212); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/14/2018

Event Type  Injury  

Manufacturer Narrative

It was not possible to verify the described failure of the stuck ascope, as no sample was returned for investigation.Neither was a lot no.Provided for the extraction of a retention sample.Based on the reported failure, the cause of failure is evaluated to be a use error.The physician used a non-compatible dlt during the procedure and did not applied any lubricant to the insertion cord, which are both described in the ifu.According to the ifu (section 1.2 - indication for use), the minimum dlt size for ascope3 slim is 37fr, which meant the physician were using a too small dlt during procedure.Using a non-compatible dlt is included in the risk evaluation of the device and is evaluated to be acceptable.Costumer also stated that the patient was not affected by the reintubation.Furthermore, is it stated in the ifu (section 4.2 - operation of ascope3), that the insertion cord need to be lubricated before insertion.The physician inserted the scope without any lubricant, hence this possibly increased the risk of the insertion cord getting stuck inside the dlt.

Event Description

The physician inserted an ascope3 slim into a 35fr double lumen tube (dlt), without any lubrication and the scope got stuck inside the tube.Reintubation of the patient was required.Patient condition was not affected.

• Brand Name: AMBU ASCOPE 3 SLIM
• Type of Device: BRONCHOSCOPE
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, dk 2750 ; DA 2750
• MDR Report Key: 12142044
• MDR Text Key: 260690140
• Report Number: 1220828-2018-00006
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/15/2018,06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 402001000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/14/2018
• Event Location: Hospital
• Date Report to Manufacturer: 05/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention