MAUDE Adverse Event Report: COVIDIEN LP - SUPERDIMENSION INC UNKNOWN EXTENDED WORKING CHANNEL; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number UNKNOWN EXTENDED WORKING CHANNEL

Device Problems Erratic or Intermittent Display (1182); Failure to Advance (2524); Device Displays Incorrect Message (2591); Application Program Problem (2880); Connection Problem (2900)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/17/2020

Event Type  Injury  

Event Description

According to the reporter during a procedure, the system kept flickering and was saying that the locatable guide decoupled and would not recognized the locatable guide and extended working channel, they tried a new kit however the same result occurred.It would say decoupled and when going to the lower lobes the error would be removed.They pulled back to the main carina and the issue came back.A 3rd kit was tried and the same issue occurred.It would appear normal with the locatable guide in the extended working channel position.The device eventually shut off.The patient was under conscious sedation.The physician was not able to complete the superdimension portion of the case nor was the case completed by other means.

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNKNOWN EXTENDED WORKING CHANNEL
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• MDR Report Key: 12685751
• MDR Text Key: 282344929
• Report Number: 3004962788-2021-00096
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN EXTENDED WORKING CHANNEL
• Device Catalogue Number: UNKNOWN EXTENDED WORKING CHANN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other