MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. BIOGUARD AIR/WATER AND SUCTION KIT; BIOPSY VALVE

Model Number	00711784
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/06/2018
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 fluid spray occurred during withdrawal of a forceps device through the biopsy valve.The subject biopsy valve was replaced with another biopsy valve, and the procedure was completed.The biopsy valve was not returned to us endoscopy.The lot number of the device was unknown.The instructions for use include the following statements: "do not leave a device hanging from the valve.Doing so can cause the creation of a larger valve slit/hole that may cause leakage.If the lid of the valve is opened while attached to the endoscope during a procedure, scope suction will be compromised and leakage may occur.If leakage occurs, a sterile gauze should be used to cover the valve." in-service training has been provided to the user.
Event or Problem Description
The user facility reported fluid spray from the bioshield biopsy valve.The spray did not contact the user, and there was no report of harm to the patient or user.

• Brand Name: BIOGUARD AIR/WATER AND SUCTION KIT
• Common Device Name: BIOPSY VALVE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 7504004
• Report Number: 1528319-2018-00016
• Device Sequence Number: 1528668
• Product Code: ODC
• UDI-Device Identifier: 00816765013007
• UDI-Public: (01)00816765013007
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K151345
• 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): 05/10/2018

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: No Information
• Device Model Number: 00711784
• Device Catalogue Number: 00711784
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2018
• Initial Report FDA Received Date: 05/10/2018
• Patient Sequence Number: 1