MAUDE Adverse Event Report: COVIDIEN ILLUMISITE; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Device Problems Display or Visual Feedback Problem (1184); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 01/25/2021

Event Type  malfunction  

Event Description

Navigation registration completed uneventfully.During biopsy attempts, received "reconnect locatable guide" error message.Error disappeared when lg unlocked, reappeared when lg relocked.Further attempts to continue navigation would not work because emn estimated position of lg began to fluctuate wildly (discordance between virtual bronchoscopic view when lg in ewc vs when lg was out of ewc).There was no unusual pressure or force applied to the scope or lg during the procedure.All cords were disconnected/reconnected without improvement.Lg replaced, error no longer present.Suspect lg malfunctioned.

• Brand Name: ILLUMISITE
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11372100
• MDR Text Key: 233271498
• Report Number: 11372100
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/25/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21535 DA