MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. BIOGUARD AIR/WATER AND SUCTION VALVES

Model Number	00711780
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The single use bioguard air/water & suction valve is used to control the air / water function of an endoscope during gi endoscopic procedures.The user was not using facial ppe and was struck on the cheek by a portion of the device.The device includes a spring-loaded valve cap.Device breakage during use may result in release of the spring or cap.The device subject of this event was not returned to us endoscopy for evaluation.The device subject of this event was a component of a via compliance kit ((b)(4)).The device history record was reviewed and confirmed the bioguard was manufactured to specification.There have been no other complaints associated with this lot.The instructions for use include the following statements: "inspect the package for shipping or handling damage.If damage is evident, do not use these devices.Confirm that the valve fits securely and that there is no gap between the valve end cap and the endoscope.Actuate the valve by pressing and releasing a few times to confirm smooth function.".In-service training was completed on 11/19/2018; there have been no further issues reported since.
Event or Problem Description
The user facility reported that the bioguard air/water & suction valve device became disassembled during use, causing a portion the valve to strike a user.No injury was reported, and no treatment was sought or administered.

• Brand Name: BIOGUARD AIR/WATER AND SUCTION VALVES
• Common Device Name: AIR/WATER AND SUCTION VALVES
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 8161294
• Report Number: 1528319-2018-00040
• Device Sequence Number: 2118887
• Product Code: ODC
• UDI-Device Identifier: 00816765012772
• UDI-Public: (01)00816765012772
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/11/2020
• Device Model Number: 00711780
• Device Catalogue Number: 00711780
• Device Lot Number: 1803021
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 12/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1