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

Model Number CCB-7-240-3-S

Device Problems Break (1069); Difficult to Open or Close (2921)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event 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
• Type of Device: ENDOSCOPIC CYTOLOGY BRUSH
• Manufacturer (Section D): WILSON-COOK MEDICAL; winston-salem NC 27105
• MDR Report Key: 15242186
• MDR Text Key: 298212600
• Report Number: MW5111514
• Device Sequence Number: 1
• Product Code: FDX
• UDI-Device Identifier: 00827002221086
• UDI-Public: (01)00827002221086
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• 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 Manufacturer Received: Not provided
• Initial Date FDA Received: 08/16/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1