MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC CYTOLOGY BRUSH - BRONCHOSCOPE

Model Number 00711401

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

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

Event Date 06/24/2015

Event Type  malfunction  

Manufacturer Narrative

The disposable cytology brush is designed to collect cells from the mucosa of the gi tract or bronchus.The user reported a device became frayed and bent during use.There was no harm to the patient or user as a result of the event.The event was reported through user facility medwatch, report #(b)(4).The device was not returned for examination.A review of the manufacturing record found all test and inspections were completed with acceptable results.A us endoscopy product specialist observed the product use during the next two similar procedures, which were completed without incident.Device was not returned.

Event Description

The disposable cytology brush is designed to collect cells from the mucosa of the gi tract or bronchus.The user reported a device became frayed and bent during use.There was no harm to the patient or user as a result of the event.The event was reported through user facility medwatch, report (b)(4).

• Brand Name: CYTOLOGY BRUSH - BRONCHOSCOPE
• Type of Device: CYTOLOGY BRUSH
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: michael oleksa ; 5976 heisley road; mentor, OH 44060 ; 4403586263
• MDR Report Key: 5039718
• MDR Text Key: 25236386
• Report Number: 1528319-2015-00022
• Device Sequence Number: 1
• Product Code: FDX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K924104
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Report Date: 08/28/2015

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: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: 00711401
• Device Catalogue Number: 00711401
• Device Lot Number: 1416255
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/13/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other