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

Model Number	00711125
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The bioshield biopsy valve is intended for use with gastrointestinal endoscopes.It is not intended for use with a bronchoscope.Therefore, the reported usage was off-label and the device subject of this event has not been evaluated.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: "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." steris endoscopy has requested that the distributor offer in-service training to the user facility.No further issues have been reported.
Event or Problem Description
The distributor reported that during usage of the bioshield biopsy valve on a bronchoscope, fluid projected from the cap when injecting saline.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
• MDR Report Key: 10125310
• Report Number: 1528319-2020-00017
• Device Sequence Number: 16606274
• Product Code: ODD
• UDI-Device Identifier: 10724995183490
• UDI-Public: (01)10724995183490
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 06/05/2020

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: 11/26/2022
• Device Model Number: 00711125
• Device Catalogue Number: 00711125
• Device Lot Number: 1916362
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2020
• Initial Report FDA Received Date: 06/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1