MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. CYTOLOGY BRUSH; ENDOSCOPIC CYTOLOGY BRUSH

Catalog Number 00711401

Device Problems Detachment Of Device Component (1104); Material Protrusion/Extrusion (2979)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/19/2015

Event Type  malfunction  

Event Description

During a bronchoscopy procedure, while inserting the brush when asked to "brush," the handle came off and the plastic part near the handle bunched up.
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manufacturer response for cytology brush, cytology brush bronchoscope (per site reporter).
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the product specialist will pick up the device and return it.

• Brand Name: CYTOLOGY BRUSH
• Type of Device: ENDOSCOPIC CYTOLOGY BRUSH
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor, OH 44060
• MDR Report Key: 4598405
• MDR Text Key: 5633330
• Report Number: 4598405
• Device Sequence Number: 1
• Product Code: FDX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 01/20/2015

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: Nurse
• Device Catalogue Number: 00711401
• Device Lot Number: 1416255
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/20/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/13/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/20/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1