MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. CLEANING BRUSH - CHANNEL

Model Number 00711601

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2014

Event Type  malfunction  

Event Description

The cleaning brush - channel (00711601) is disposable and is intended for single-use during endoscope cleaning.Us endoscopy received a medwatch report (mw5039251) on 04/02/2015, with event description: 'during ebd procedure, tip of brush fell out of scope.Physician spotted it immediately and removed.No harm to patient.' reference mw (b)(4).

Manufacturer Narrative

The cleaning brush - channel (00711601) is disposable and is intended for single-use during endoscope cleaning.Us endoscopy received a medwatch report (mw5039251) on 04/02/2015, with event description: 'during ebd procedure, tip of brush fell out of scope.Physician spotted it immediately and removed.No harm to patient.' in follow up communication, the reporter at the user facility explained the distal brush head was retained in the endoscope after cleaning, and the brush head made contact with the patient during the next procedure.The user stated the brush head was seen immediately by the physician and retrieved.The user confirmed there was no harm to the patient as a result of the brush head contact nor as a result of the retrieval.The user records did not include the endoscope model number.The device was not available for return.The product instructions for use (ifu) include: see scanned pages.A review of the device history record (cleaning brush - channel, 00711601 lot 1412701, (b)(4) units) finds no anomalies noted during manufacture, and finds acceptable results for all tests and inspections.A review of the complaint history finds no other complaints of any type associated with cleaning brush - channel 00711601 lot 1412701.This report will be updated if further information becomes available.

• Brand Name: CLEANING BRUSH - CHANNEL
• Type of Device: CLEANING BRUSH
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd.; mentor OH 44060
• Manufacturer Contact: michael oleksa ; 5976 heisley rd.; mentor, OH 44060 ; 4403586263
• MDR Report Key: 4747295
• MDR Text Key: 5706109
• Report Number: 1528319-2015-00011
• 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: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: 00711601
• Device Catalogue Number: 00711601
• Device Lot Number: 1412701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2015
• Initial Date FDA Received: 04/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention