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

Model Number 00711124

Device Problem Leak/Splash (1354)

Patient Problem Exposure to Body Fluids (1745)

Event Date 06/11/2018

Event Type  malfunction  

Manufacturer Narrative

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.There was no reported treatment due to contact with fluids.Devices subject of the report were not available for investigation, and the lot numbers were unknown.The instructions for use include the following statements: "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 was completed by the distributor on june 18th, 2018.No further issues have been reported since the in-service was completed.

Event Description

The distributor in the (b)(6) received report of bodily fluid spray with resultant patient and user contact during insertion and withdrawal of devices through bioshield biopsy valves.

• Brand Name: BIOSHIELD BIOPSY VALVE
• Type of Device: BIOPSY VALVE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley rd; mentor, OH 44060 ; 4403586251
• MDR Report Key: 7705878
• MDR Text Key: 114947766
• Report Number: 1528319-2018-00019
• Device Sequence Number: 1
• Product Code: ODD
• UDI-Device Identifier: 00816765011034
• UDI-Public: (01)00816765011034
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K070420
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 00711124
• Device Catalogue Number: 00711124
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1