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 Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned to us endoscopy.The lot history record was reviewed and found no issues during manufacture; the device was built to specification.The instructions for use contain the following warnings and precautions: "exposure to bodily fluids may occur during connection or disconnection of these devices; adherence to body substance isolation protocols is the responsibility of the user.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 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 user facility reported that post procedure, the biopsy valve in the bioguard air/water and suction valve kit sprayed fluid.There was no contact with 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: 7099659
• Report Number: 1528319-2017-00037
• Device Sequence Number: 1091253
• Product Code: ODC
• UDI-Device Identifier: 00816765013007
• UDI-Public: (01)00816765013007(17)190807(10)1708048
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K151345
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/08/2017

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: Other
• Device Expiration Date: 08/07/2019
• Device Model Number: 00711784
• Device Catalogue Number: 00711784
• Device Lot Number: 1708048
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2017
• Initial Report FDA Received Date: 12/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1