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

Catalog Number 00711401

Device Problems Bent (1059); Material Frayed (1262)

Patient Problem No Information (3190)

Event Date 06/24/2015

Event Type  malfunction  

Event Description

This device was frayed and bent.

• 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: 4945253
• MDR Text Key: 6257386
• Report Number: 4945253
• 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: 07/20/2015

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: Invalid Data
• 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: 07/20/2015
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 07/28/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/20/2015
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES