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

Model Number	00711125
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	05/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user facility reported that the event occurred during intubation of the endoscope.User facility personnel reported that a large amount of water had been used to irrigate the body cavity and abdominal pressure was being applied at the time of the event.The technician was wearing ppe and did not come into direct contact with the bodily fluids.The device subject of the reported event was not returned for evaluation.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." us endoscopy has offered in-service training to the user facility and the offer has been accepted and is scheduled to be completed june 25th, 2019.No additional issues have been reported.
Event or Problem Description
The user facility reported the cap of the bioshield biopsy valve opened during a procedure, resulting in a spray of bodily fluid which contacted a technician's ppe.No harm to patient or users was reported.

• 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: 8718504
• Report Number: 1528319-2019-00024
• Device Sequence Number: 1756411
• Product Code: ODD
• UDI-Device Identifier: 00816765013397
• UDI-Public: (01)00816765013397
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K070420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/20/2019

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: 03/10/2022
• Device Model Number: 00711125
• Device Catalogue Number: 00711125
• Device Lot Number: 1903408
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 06/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1