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

Model Number	00711126
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	07/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history record indicates no issues during manufacture; the device was manufactured to specification.The subject device was not returned to us endoscopy.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.Follow up has confirmed no additional issues.Device not returned to manufacturer.
Event or Problem Description
The biopsy valve is used to cover the opening to the biopsy/suction channel inlet of a gastrointestinal endoscope.The 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 during a procedure the lid of the biopsy valve opened and sprayed a nurse with bodily fluid.The nurse was wearing proper personal protective equipment however the fluid came in contact with her skin.The nurse washed the affected skin and no further treatment was sought.There was no report of harm to the patient.

• Brand Name: BIOSHIELD BIOPSY VALVE
• Common Device Name: BIOPSY VALVE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 6817396
• Report Number: 1528319-2017-00024
• Device Sequence Number: 16158130
• Product Code: ODD
• UDI-Device Identifier: 00816765011058
• UDI-Public: (01)00816765011058(17)200601(11)170602(10)1709435
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K07020
• 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): 08/24/2017

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: Physician
• Device Expiration Date: 06/01/2020
• Device Model Number: 00711126
• Device Catalogue Number: 00711126
• Device Lot Number: 1709435
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2017
• Initial Report FDA Received Date: 08/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other