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

Model Number 00711652

Device Problem Detachment Of Device Component (1104)

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 a use of the infinity sampling device.The physician reported the event had occurred many months prior, estimated to have occurred in early spring 2014.The physician described advancing the device into the hepatic duct and completing two to three brushing cycles prior to the brush head becoming detached from the drive wire while in the duct.The brush head was removed, and the physician reported the patient did not require any additional medical or surgical treatment.

Manufacturer Narrative

The disposable infinity sampling device is intended to be used to retrieve cytological cell samples in the gastrointestinal tract.The device was not returned for evaluation and the lot number was unknown.The lot history records for all lots which had shipped to the customer were reviewed, and the manufacturing methods and inspection were confirmed acceptable.This report will be updated if additional 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 oleksa ; 5976 heisley rd.; mentor, OH 44060
• MDR Report Key: 4071860
• MDR Text Key: 17618503
• Report Number: 1528319-2014-00015
• 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: 08/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00711652
• Device Catalogue Number: 00711652
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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