MAUDE Adverse Event Report: CONMED CORPORATION CYTOLOGY BRUSH; ENDOSCOPIC CYTOLOGY BRUSH

Lot Number 202303164

Patient Problem Foreign Body In Patient (2687)

Event Date 01/30/2024

Event Type  Injury  

Event Description

During procedure dr.(b)(6) utilized harrell unshealthed cytology brush (lot # 202303164) to attempt brushing of right lower lobe of lung.Upon withdrawal of disposable sheath, it was noted that the brush head was not attached.Dr.(b)(6) used fluoroscopy to locate brush and removed with biopsy forceps.Brush head appeared intact.All brushes with this lot number were removed from room and stock at this time.

• Brand Name: CYTOLOGY BRUSH
• Type of Device: ENDOSCOPIC CYTOLOGY BRUSH
• Manufacturer (Section D): CONMED CORPORATION
• MDR Report Key: 18660757
• MDR Text Key: 334896778
• Report Number: MW5151131
• Device Sequence Number: 1
• Product Code: FDX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/02/2024

1 Device was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 202303164
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/06/2024
• Is This a Reprocessed and Reused Single-Use Device?: No