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

Model Number	00711652
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A portion of the device subject of this event was returned to steris endoscopy for evaluation.However, the distal end of the returned device had been removed and therefore an examination of the reported detachment could not be completed.The device history record was reviewed and confirmed the device was manufactured to specification.There have been no other complaints associated with this lot.The instructions for use include the following statements: "do not force the brush through the endoscope's channel.Reduce angulation of the scope if resistance is met.Prior to procedure, actuate the handle several times to be sure the brush functions properly.If the unit does not function properly, or there is evidence of damage (e.G., bent brush, bent brush stem, kinked catheter), do not use this product and contact your local product specialist." steris endoscopy provided in-service training to the user facility on use of the infinity sampling device on (b)(6) 2020.No further issues have been reported.
Event or Problem Description
The user facility reported that while sampling a stricture in the biliary tract the brush of an infinity sampling device became detached.The brush component was removed from the biliary tract with a forceps, then retrieved with a snare and hood.The procedure was completed successfully, and the tissue sample was obtained.

• Brand Name: INFINITY ERCP SAMPLING DEVICE
• Common Device Name: SAMPLING DEVICE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor, oh
• MDR Report Key: 10125303
• Report Number: 1528319-2020-00016
• Device Sequence Number: 13915210
• Product Code: FDX
• UDI-Device Identifier: 00724995184049
• UDI-Public: (01)00724995184049
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151889
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/05/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/02/2023
• Device Model Number: 00711652
• Device Catalogue Number: 00711652
• Device Lot Number: 2002834
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2020
• Initial Report FDA Received Date: 06/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1