MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. INFINITY SAMPLING DEVICE

Model Number 00711652

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

On (b)(6) 2014, a complaint was received reporting brush head detachment during use of the infinity sampling device.The brush head was reported to have become detached when removing the device from a stricture in the common bile duct.The brush head was removed, and the patient did not require any additional treatment.

Manufacturer Narrative

The disposable infinity sampling device is intended to be used to retrieve cytological cell samples in the gastrointestinal tract.A review of the lot history record finds no anomalies recorded during manufacture of the lot.The device has been returned and is under examination.The report will be updated if further information becomes available.

• Brand Name: INFINITY SAMPLING DEVICE
• Type of Device: SAMPLING DEVICE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd.; mentor OH 44060
• Manufacturer Contact: michael oleska ; 5976 heisley rd.; mentor, OH 44060 ; 4403586263
• MDR Report Key: 4342128
• MDR Text Key: 5215842
• Report Number: 1528319-2014-00026
• Device Sequence Number: 1
• Product Code: FDX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: 00711652
• Device Catalogue Number: 00711652
• Device Lot Number: 1415238
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• 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): Required Intervention