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

Model Number 00711652

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

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.In follow up communication, the physician reported the pancreatic duct and completing two to three brushing cycles prior to the brush head becoming detached and remaining in the distal duct.The physician reported no additional surgical or medical treatment was required, and no complications as a result of this event were reported.

Manufacturer Narrative

The disposable infinity sampling device is intended to be sued to retrieve cytological cell samples in the gastrointestinal tract.The device was not returned for evaluation and the lot number was not known.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 ; 4403586263
• MDR Report Key: 4071877
• MDR Text Key: 4896560
• Report Number: 1528319-2014-00014
• 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: Other
• Type of Report: Initial
• Report Date: 08/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 07/23/2014
• Initial Date FDA Received: 08/12/2014
• 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): Other