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

Model Number 00711652

Device Problem Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/30/2015

Event Type  Injury  

Event Description

The disposable infinity sampling device is intended to be used to retrieve cytological cell samples in the gastrointestinal tract.A distributor reported the device brush head detached and was retained above a stenosis while sampling in the low biliary duct.The patient was not harmed by the retrained brush head.A stent was placed to reduce the stenosis.The physician determined the brush head would be retrieved after expansion of the stent in a later procedure.In follow up communications, the distributor reported the brush head was retrieved in a second procedure, with no harm to the patient as a result of the retained brush head and no harm to the retrieval.

Manufacturer Narrative

The disposable infinity sampling device is intended to be sued to retrieve cytological cell samples in the gastrointestinal tract.A distributor reported the device brush head detached and was retained above stenosis while sampling in the lower biliary duct.The patient was not harmed by the retained brush head.A stent was placed to reduce the stenosis.The physician determined the brush head would be retrieved after expansion of the stent, in a later procedure.In follow up communications, the distributor reported the brush head was retrieved in a second procedure, with no harm to the patient as a result of the retained brush head and no harm due to the retrieval.Examination of the returned device found evidence of bending at the distal catheter.Examination of the returned brush head found similar evidence of bending on the wire stem of the brush head.The instructions for use warn against forcing the device through the endoscope channel and instructs to reduce elevator angulation if resistance is met.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 ; 4403586263
• MDR Report Key: 4959515
• MDR Text Key: 6191663
• Report Number: 1528319-2015-00020
• Device Sequence Number: 1
• Product Code: FDX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K103437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: 00711652
• Device Catalogue Number: 00711652
• Device Lot Number: 1418194
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/15/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention