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

Model Number 00711553

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/04/2017

Event Type  malfunction  

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 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
• Type of Device: WATER BOTTLE CAP
• 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: 6817403
• MDR Text Key: 83646215
• Report Number: 1528319-2017-00025
• Device Sequence Number: 1
• Product Code: FEQ
• UDI-Device Identifier: 00816765013335
• UDI-Public: (01)00816765013335(17)180604(11)170604(10)1709622
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163424
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other