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 Information (3190)

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)(6) 2015, a us endoscopy product specialist reported a brush head detachment had occurred during use of the infinity sampling device.The date of the event was unk, estimated to have occurred approx one week prior.The brush head broke off the device while brushing a proximal stricture in the common bile duct.The procedure was delayed for 15 minutes while the brush head was retrieved with a rat-tooth grasping device.The retrieved brush head contained sufficient sampling material, therefore no other sampling devices were needed to complete the procedure.There was no harm to the pt as a result of the brush head detachment nor as a result of the brush head retrieval.The physician stated he did not report the event at the time of occurrence because he did not hold the device responsible.The physician believed he had snapped the brush head in the endoscope elevator during brushing.The physician requested no further contact concerning this event.

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, a us endoscopy product specialist reported a brush head detachment had occurred during use of the infinity sampling device.The date of the event was unk, estimated to have occurred approx one week prior.The brush head broke off the device while brushing a proximal stricture in the common bile duct.The procedure was delayed for 15 minutes while the brush head was retrieved with a rat-tooth grasping device.The retrieved brush head contained sufficient sampling material, therefore no other sampling devices were needed to complete the procedure.There was no harm to the pt as a result of the brush head detachment nor as a result of the brush head retrieval.The physician stated he did not report the event at the time of occurrence because he did not hold the device responsible.The physician believed he had snapped the brush head in the endoscope elevator during brushing.The instructions for use includes warning 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 and the lot number was unk.This report will be updates if add'l 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 oleksa ; 5976 heisley rd.; mentor, OH 44060 ; 4403586263
• MDR Report Key: 4722884
• MDR Text Key: 5739815
• Report Number: 1528319-2015-00010
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/20/2015

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?: No
• 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
• Initial Date Manufacturer Received: 03/27/2015
• Initial Date FDA Received: 04/20/2015
• 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