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

Model Number 00711652

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/12/2015

Event Type  Injury  

Event Description

The disposable infinity sampling device is intended to be used to retrieve cytological cell samples in the gastrointestinal tract.On (b)(4) 22015, us endoscopy received a medwatch report (uf report # (b)(4)) with event description: 'during the procedure, it was noticed that a foreign body was in the biliary duct.It was retrieved with no complications or injury to the pt.It was noticed that the object was from the biliary cytology brush that was used for the procedure.The original intended procedure was upper eus, ercp.' through follow up communications with their user facility, us endoscopy has learned this event has been associated with the improper positioning of the endoscope elevator during the sampling procedure.

Manufacturer Narrative

The disposable infinity sampling device is intended to be used to retrieve cytological cell samples in the gastrointestinal tract.On (b)(6) 2015, us endoscopy received a medwatch report (uf report # (b)(4)) with event description: 'during the procedure, it was noticed that a foreign body was in the biliary duct.It was retrieved with no complications or injury to the pt.It was noticed that the object was from the biliary cytology brush that was used for the procedure.The original intended procedure was upper eus, ercp.' through follow up communications with the user facility, us endoscopy has learned this event has been associated with the improper positioning of the endoscope elevator during the sampling procedure.The instructions for use warns against forcing the brush through the scope, and includes directions to reduce angulation if resistance is met and directions to perform brushing with the elevator in an open position.The device was not returned for eval.A review of the manufacturing record finds no anomalies noted during manufacture, and tests and inspection were performed with acceptable results documented.This report will be updated if additional info 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: 4768431
• MDR Text Key: 5794771
• Report Number: 1528319-2015-00013
• 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: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/08/2015

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 Model Number: 00711652
• Device Catalogue Number: 00711652
• Device Lot Number: 1410424
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2015
• Initial Date FDA Received: 05/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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