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

Model Number	00711124
Health Effect - Clinical Codes	Conjunctivitis (1784); Chemical Exposure (2570)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user facility reported fluid leak from the bioshield valve following passage of instruments through the device.The user facility has declined to provide information regarding treatment of the reported conjunctivitis.The user facility has declined to provide information regarding usage of ppe by facility personnel.The device subject of the reported event was not retained by the user facility for evaluation.The user facility was unable to provide the lot number of the device subject of this event.The instructions for use include the following statements: "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.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." the distributor has offered in-service training on the use of bioshield biopsy valves to the user facility; however, the user facility has declined.No additional issues have been reported.
Event or Problem Description
The distributor reported user contact (facial) with fluid spray from the bioshield biopsy valve.The user is reported to have subsequently developed conjunctivitis.

• 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: 8875113
• Report Number: 1528319-2019-00030
• Device Sequence Number: 19467363
• Product Code: ODD
• UDI-Device Identifier: 00816765011034
• UDI-Public: (01)00816765011034
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K070420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/08/2019

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 Model Number: 00711124
• Device Catalogue Number: 00711124
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 08/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1