MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. VIA COMPLIANCE KIT

Model Number	00719701
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event occurred during an upper egd sampling procedure.A forceps device was inserted through the endoscope accessory channel and pushed the brush head into the duodenum.The brush head passed into the small intestine and the physician did not attempt retrieval.The double-header cleaning brush is included within the via compliance kit.The lot numbers of the procedure kit and the cleaning brush are unknown.The device subject of this event was not returned to us endoscopy for evaluation.The instructions for use include the following statements: "if the channels are known to be occluded or resistance is met in attempting to pass the brush through the endoscope, do not force the cleaning brush through the endoscope.Use only in channels 2.0mm and larger and in control head valve openings.Dispose of the cleaning brush after initial use.The mechanical attachment of the brush(es) to the plastic sheath cannot be guaranteed to be reliable or secure following initial use." the facility accepted us endoscopy's offer of in-service training.The training was completed on (b)(6) 2018; no further issues have been reported.
Event or Problem Description
The user facility reported that the brush head of a double-header cleaning brush became detached during cleaning and was retained in the endoscope accessory channel.The brush head was pushed into the patient during the next procedure.The physician chose not to retrieve the brush head, instead allowing it to pass naturally.There was no reported harm to the patient.

• Brand Name: VIA COMPLIANCE KIT
• Common Device Name: COMPLIANCE KIT
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 8073345
• Report Number: 1528319-2018-00037
• Device Sequence Number: 13817865
• Product Code: NWU
• UDI-Device Identifier: 00816765012390
• UDI-Public: (01)00816765012390
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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): 11/15/2018

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
• Operator of Device: Health Professional
• Device Model Number: 00719701
• Device Catalogue Number: 00719701
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 11/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1