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

Model Number	00711499
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The disposable infinity cytology brush is intended to be used to retrieve cytological cell samples in the gastrointestinal tract.A portion of the device was returned to us endoscopy.The brush head was not returned.Examination of the return confirmed the report of a detached brush head, however the report could not be fully investigated without the brush head component.The device history records for this lot was reviewed and confirmed the devices were manufactured to specification.There have been no other complaints associated with devices from this lot.The device's instructions for use state: "the brush should never be forced through the endoscope's channel.If resistance is met due to excess angulation of the endoscope, it may be necessary to decrease the angulation to allow passage of the brush.Prior to clinical use, familiarize yourself with the device and read all the instructions for use.Inspect the package for shipping or handling damage.If damage is evident, do not use this device and contact your product specialist.Fully retract and deploy the spool handle and thumb ring 3-4 times to ensure the device functions properly and is not damaged.If damage is evident, do not use this device." us endoscopy offered in-service training, however the user facility has declined.
Event or Problem Description
The user facility reported that during a procedure, the distal brush head became detached from the infinity cytology brush device.The brush head was immediately retrieved with no report of patient harm due to the detached component nor the retrieval.

• Brand Name: INFINITY CYTOLOGY BRUSH
• Common Device Name: CYTOLOGY BRUSH
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 7602839
• Report Number: 1528319-2018-00017
• Device Sequence Number: 19181511
• Product Code: FDX
• UDI-Device Identifier: 00816765012185
• UDI-Public: (01)00816765012185
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K924104
• 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): 06/14/2018

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: Physician
• Device Expiration Date: 12/11/2020
• Device Model Number: 00711499
• Device Catalogue Number: 00711499
• Device Lot Number: 1719893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2018
• Initial Report FDA Received Date: 06/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1