MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. DOUBLE HEADER CLEANING BRUSH; ENDOSCOPE CLEANING BRUSH

Model Number 00711609

Device Problems Break (1069); Detachment Of Device Component (1104); Mechanical Jam (2983)

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

Event Date 01/16/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014, us endoscopy received a medwatch report regarding one of our devices.The device is a cleaning brush that is used to clean the channels of an endoscope after an endoscopic procedure.It was reported that, while cleaning the colonoscope, a technician passed the cleaning brush through the suction channel 3 times ensuring they saw the brush head come out of the distal end.It is assumed the brush broke off when removing it from the proximal end of the suction channel after the third pass.The scope was then reprocessed according to established guidelines.Later that day, the scope was used in another colonoscopy procedure.The scope was test at bedside before a procedure and the tech confirmed it was working properly.The doctor then inserted the colonoscope into the patient and depressed the suction button.The scope didn't seem to be working properly so the doctor pushed down on the suction button for about 30 seconds.At this point the scope malfunctioned.The doctor removed the suction buttons and saw the brush head jammed in the hole.After removal, the scope worked fine.Another scope was used to successfully complete the procedure.There was no reported harm to the patient.

Manufacturer Narrative

The device involved was received back at the manufacturer facility and is currently under investigation.We are filing this mdr based on the medwatch report submitted by the facility.

• Brand Name: DOUBLE HEADER CLEANING BRUSH
• Type of Device: ENDOSCOPE CLEANING BRUSH
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd.; mentor OH 44060
• Manufacturer Contact: carroll martin ; 5976 heisley rd.; mentor, OH 44060 ; 4403586259
• MDR Report Key: 3919562
• MDR Text Key: 4582326
• Report Number: 1528319-2014-00004
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K924103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/04/2014

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: 12/31/2016
• Device Model Number: 00711609
• Device Catalogue Number: 00711609
• Device Lot Number: 1332905
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/18/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2014
• Initial Date FDA Received: 03/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2013
• 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