MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. DOUBLE HEADER - CHANNEL AND CONTROL HEAD COMBO; CLEANING BRUSH

Model Number 00711609

Device Problems Mechanical Problem (1384); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2014

Event Type  No Answer Provided  

Event Description

On (b)(6) 2014, us endoscopy received a report a brush head detached during use of the cleaning brush, double header - channel and control head combo (b)(4).The initial report stated the event occurred during endoscope cleaning and was not used in a procedure.On (b)(6) 2014, us endoscopy received additional information from the user, stating the brush head was retained in the endoscope, and the endoscope was then used in two patient procedures.During the first procedure, the endoscope suction button became jammed, the endoscope was removed from the procedure and sent for service.After servicing, the endoscope was reprocessed and used in the next procedure.During the next procedure, the endoscope suction button again jammed.The endoscope was removed from the procedure, and a brush head was found lodged in the scope channel.There was no report of patient harm.

Manufacturer Narrative

Follow up information provided by the user includes the endoscope manufacturer has provided the staff with in-service instruction on cleaning.A review of the lot history record indicates no anomalies in the manufacture of the lot.This report will be updated if additional information becomes available.

• Brand Name: DOUBLE HEADER - CHANNEL AND CONTROL HEAD COMBO
• Type of Device: CLEANING BRUSH
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd.; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley rd.; mentor, OH 44060 ; 4403586251
• MDR Report Key: 4294080
• MDR Text Key: 5052745
• Report Number: 1528319-2014-00024
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/25/2014

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: 09/30/2017
• Device Model Number: 00711609
• Device Catalogue Number: 00711609
• Device Lot Number: 1418608
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2014
• Initial Date FDA Received: 11/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2014
• 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