PULL THRU CLEANING DEVICE 100405

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-07 for PULL THRU CLEANING DEVICE 100405 manufactured by Medivators.

Event Text Entries

[173930974] The endoscopy department changed to a new scope lumen cleaning brush (pull-thru lumen channel brush). The decision to change to this new system was to achieve optimal cleaning. Prior to using the new brushes, the representative educated the endoscopy team on how to use the brushes. It was decided that the new brushes were not to be used until the old brushes were used up. On [date redacted], the endoscopy team were instructed they could begin to use the new brushes. During the cleaning process, the endoscopy technicians found that the new brush applied to a balloon lumen did not perform as intended. This new brush could not be pulled through the balloon lumen channel and the effective brush component did not reach the end of this channel. This information was communicated to the department manager. Use of this device was stopped at this time and stored scopes were reprocessed using the former brush method. The manufacturer of the brush listed that the new brush could be used with the endoscopic and endobronchial ultrasound units owned by this facility. Nine patients received scope procedures within this two week timeframe with a balloon lumen. Four patients (two endoscopic ultrasounds, two endobronchial ultrasounds) had scopes cleaned with the new brush. Follow up: infection prevention and endoscopy reviewed the medical records of the patients who had scopes inadequately cleaned with the new brush. Many various factors were applied to assess infection risk for these cases. The conclusion was that it is assumed all scope processing steps were followed. The new brush applied to a balloon lumen did not perform as intended. The manufacturer of the brush listed that the new brush could be used with the eus and ebus models owned by this facility. No blood borne pathogens were identified in the total patient population (9). No biopsies were collected. No complications (balloon rupture, perforation, bleeding) occurred. Risk has been assessed to be low. Action plan: includes reviewing the importance of immediate communication to endoscopy leads when a problem is identified with cleaning and disinfecting a scope. Update scope policies and procedures (in process) for specific scope procedures. Report to manufacturer regarding the manufacturer directions for use of this device.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9557473
• MDR Report Key: 9557473
• Date Received: 2020-01-07
• Date of Report: 2019-12-18
• Date of Event: 2019-11-17
• Report Date: 2019-12-20
• Date Reported to FDA: 2019-12-20
• Date Reported to Mfgr: 2020-01-07
• Date Added to Maude: 2020-01-07
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PULL THRU CLEANING DEVICE
• Generic Name: ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE
• Product Code: MNL
• Date Received: 2020-01-07
• Model Number: 100405
• Catalog Number: 100405
• Lot Number: 438970
• Device Availability: Y
• Device Age: 1 DA
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDIVATORS
• Manufacturer Address: 14605 28TH AVE N MINNEAPOLIS MN 55447 US 55447

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-01-07