MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. AQUASHIELD SYSTEM CO2 - FUJINON; WATER BOTTLE CAP

Model Number	00711553
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history record indicates no issues during manufacture; the device was manufactured to specification.The subject device was not returned to us endoscopy.The instructions for use contain the following: "prime the air/water channel prior to insertion of the endoscope into a patient.If water pressure is low, check to see that the lid cap is tightly closed.Check that the endoscope connector is firmly attached to the endoscope." in-service training has been provided to the user.
Event or Problem Description
The aquashield system co2 - fujinon is intended to be used with an air or carbon dioxide (co2) source from an endoscope with the purpose of supplying sterile water to the endoscope during endoscopic procedures.It is compatible with u.S.Commercially available sterile water bottles.This device is intended to be used for not more than 24 hours.The user facility reported during a procedure the connection between the aquashield system co2 and the endoscope was leaking sterile water.There was no report of injury to the patient or the user.

• Brand Name: AQUASHIELD SYSTEM CO2 - FUJINON
• Common Device Name: WATER BOTTLE CAP
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 6817403
• Report Number: 1528319-2017-00025
• Device Sequence Number: 41318
• Product Code: FEQ
• UDI-Device Identifier: 00816765013335
• UDI-Public: (01)00816765013335(17)180604(11)170604(10)1709622
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K163424
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 06/04/2018
• Device Model Number: 00711553
• Device Catalogue Number: 00711553
• Device Lot Number: 1709622
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2017
• Initial Report FDA Received Date: 08/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other