MAUDE Adverse Event Report: WILSON-COOK MEDICAL COLONOSCOPY CYTOLOGY BRUSH; ENDOSCOPIC CYTOLOGY BRUSH

Model Number	CCB-7-240-3-S
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Colonoscopy cytology brush would not open, handle broken, supply wasted, had to use second brush to obtain specimen.Fda safety report id# (b)(4).

• Brand Name: COLONOSCOPY CYTOLOGY BRUSH
• Common Device Name: ENDOSCOPIC CYTOLOGY BRUSH
• Manufacturer (Section D): WILSON-COOK MEDICAL; winston-salem NC 27105
• MDR Report Key: 15242186
• Report Number: MW5111514
• Device Sequence Number: 6475705
• Product Code: FDX
• UDI-Device Identifier: 00827002221086
• UDI-Public: (01)00827002221086
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/08/2024
• Device Model Number: CCB-7-240-3-S
• Device Catalogue Number: G22108
• Device Lot Number: W4544830
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/16/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown