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

Model Number ILS-1800-KT

Patient Problem Insufficient Information (4580)

Event Date 08/09/2022

Event Type  malfunction  

Event Description

During a navigational lung bronchoscopy, while using a "180 catheter", after obtaining the biopsy specimen, upon pulling the forceps out from the catheter, it appeared that plastic had been sheared off the inside of the catheter by the metal tip of the biopsy forceps.The catheter was replaced and when the anesthesiologist pulled back the et (endotracheal) tube slightly, it provided a better angle and there were no problems with this 180-catheter during the procedure.After investigation, it was thought to be due to the angulation of the catheter while attempting to reach the nodule in the upper left lobe.The angulation seems to be the reason why the forceps seem to shear off parts of the catheter when pulled out.The plastic that came from the catheter was saved in a specimen cup along with the catheter and packaging.We are entering this report only to bring this finding to the attention of others who might add a warning note to their packaging or technique education efforts.

• Brand Name: ILLUMISITE
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 17875655
• MDR Text Key: 324974113
• Report Number: 17875655
• 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: 09/20/2023,12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ILS-1800-KT
• Device Lot Number: 521869
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/20/2023
• Event Location: Hospital
• Date Report to Manufacturer: 10/05/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25550 DA
• Patient Sex: Female
• Patient Race: White