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

Model Number	00711133
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user facility reported that no devices had been passed through the biopsy port of the bioshield prior to the reported events.The devices subject of the reported event were not returned; however, the distributor returned several unused devices from the same lot.Examination and dimensional checks of the returned devices found them to be within specifications.The device history record was reviewed and confirmed the device was manufactured to specification.There have been no other complaints associated with this lot.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 provided in-service training to the customer and attempted to recreate the reported event with the customer without success.No additional issues have been reported.
Event or Problem Description
The distributor reported multiple instances of the cap of the bioshield irrigator opening during procedures, resulting in liquid being projected from the biopsy port.No harm to patients or users was reported.

• Brand Name: BIOSHIELD IRRIGATOR
• Common Device Name: BIOPSY VALVE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 8641706
• Report Number: 1528319-2019-00022
• Device Sequence Number: 2348997
• Product Code: ODD
• UDI-Device Identifier: 00816765011102
• UDI-Public: (01)00816765011102
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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): 05/24/2019

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: 11/29/2021
• Device Model Number: 00711133
• Device Catalogue Number: 00711133
• Device Lot Number: 1819735
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 05/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1