MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. BIOSHIELD IRRIGATOR; BIOPSY VALVE

Model Number	00711133
Date of Event	07/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The bioshield biopsy valve is used to cover the opening to the biopsy/suction channel inlet of a gastrointestinal endoscope.The bioshield biopsy valve provides access for endoscopic device passage and exchange, helps maintain insufflation and minimizes leakage of biomaterial from the biopsy port throughout the gastrointestinal endoscopic procedure.The bioshield irrigator (part #00711133), appropriate for use with olympus and g5 series or newer fujinon gastrointestinal endoscopes, will also allow for remote irrigation via an attached irrigation line.The bioshield irrigator includes a one-way check valve at the luer connection on the irrigation line.At the time of the reported event, the bioshield irrigator was being used in conjunction with extension tubing not manufactured by us endoscopy, contrary to the instructions for use.The device subject of this event was not returned to us endoscopy for evaluation and the lot number of said device is unknown.A review of past complaints against bioshield irrigator devices has found no other reported failures of the one-way valve.Us endoscopy has reviewed proper usage of the device and recommended tubing with the user facility personnel and there have been no further reported issues.
Event or Problem Description
The user facility reported debris in the tubing connected to the bioshield irrigator device following a procedure.No patient or user harm was reported.

• Brand Name: BIOSHIELD IRRIGATOR
• Common Device Name: BIOPSY VALVE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 7806919
• Report Number: 1528319-2018-00024
• Device Sequence Number: 4075606
• Product Code: ODD
• UDI-Device Identifier: 00816765011102
• UDI-Public: (01)00816765011102
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K070420
• 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): 08/22/2018

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: 00711133
• Device Catalogue Number: 00711133
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2018
• Initial Report FDA Received Date: 08/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1