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

Model Number	00711784
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The valve is included within the bioguard air/water and suction kit.The 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 and provides access for irrigation.The device subject of the reported event was discarded by the user facility.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 the valve".The device history record was reviewed and confirmed the device was manufactured to specification.There have been no other complaints associated with this lot.Us endoscopy has provided in-service training to the user facility, and no further issues have been reported.
Event or Problem Description
The user facility reported the lid of the biopsy valve opened, with resultant fluid spray from the device during procedural use.The fluid did not contact the user, and there was no report of harm to the patient or user.

• Brand Name: BIOGUARD AIR/WATER & SUCTION VALVES KIT
• Common Device Name: BIOPSY VALVE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 8337355
• Report Number: 1528319-2019-00011
• Device Sequence Number: 11320167
• Product Code: ODC
• UDI-Device Identifier: 00816765013007
• UDI-Public: (01)00816765013007
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 02/13/2019

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: 07/31/2020
• Device Model Number: 00711784
• Device Catalogue Number: 00711784
• Device Lot Number: 1808083
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 02/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1