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

Model Number 00711652

Device Problem Detachment Of Device Component (1104)

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

Event Date 07/21/2015

Event Type  malfunction  

Manufacturer Narrative

The disposable infinity sampling device is intended to be used to retrieve cytological cell samples in the gastrointestinal tract.The international distributor ((b)(4)) reported the device brush head became detached and was retained in the patient while sampling a malignant tumor in the common hepatic duct.The brush head was to be retrieved during an invasive surgical procedure to address the malignancy (whipple).A review of the manufacturing record found no anomalies noted during manufacture and found tests and inspections were performed with acceptable results documented.The brush head was not returned for examination.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.

Event Description

The disposable infinity sampling device is intended to be used to retrieve cytological cell samples in the gastrointestinal tract.The international distributor ((b)(4)) reported the device brush head became detached and was retained in the patient while sampling a malignant tumor in the common hepatic duct.The brush head was to be retrieved during an invasive surgical procedure to address the malignancy (whipple).

• Brand Name: INFINITY SAMPLING DEVICE
• Type of Device: CYTOLOGY BRUSH
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: michael oleksa ; 5976 heisley road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 5079142
• MDR Text Key: 26242385
• Report Number: 1528319-2015-00023
• Device Sequence Number: 1
• Product Code: FDX
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K103437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Report Date: 09/15/2015

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 Expiration Date: 04/30/2018
• Device Model Number: 00711652
• Device Catalogue Number: 00711652
• Device Lot Number: 1505487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/15/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/14/2015
• 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