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

Model Number	00711133
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The bioshield is used to cover the opening to the biopsy/suction channel inlet of a gastrointestinal endoscope.The bioshield provides access for endoscopic device passage and exchange, helps maintain insufflation, minimizes leakage of biomaterial from the biopsy port throughout the gastrointestinal endoscopic procedure and allows for remote irrigation via an attached irrigation line.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.Irrigating through the bioshield biopsy valve's irrigation line with a device in the biopsy channel requires sufficient space between the diameter of the device and the diameter of the endoscope's channel.Adequate space is required to allow fluid to pass freely at a moderate pressure so that the valve connections do not leak.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." a steris endoscopy representative has provided in-service training to the user facility.No additional issues have been reported.
Event or Problem Description
The user facility reported that fluid sprayed from the cap of the bioshield irrigator.No harm to patient or users was reported.The technician was wearing ppe and there was no report of direct contact with the fluids.

• Brand Name: BIOSHIELD IRRIGATOR
• Common Device Name: IRRIGATOR
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• MDR Report Key: 9601123
• Report Number: 1528319-2020-00004
• Device Sequence Number: 13542004
• Product Code: ODD
• UDI-Device Identifier: 00816765011102
• UDI-Public: (01)00816765011102
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 01/17/2020

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: 08/01/2022
• Device Model Number: 00711133
• Device Catalogue Number: 00711133
• Device Lot Number: 1911420
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 01/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1