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U.S. Department of Health and Human Services

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

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UNITED STATES ENDOSCOPY GROUP, INC. AQUSHIELD SYSTEM CO2 - FUJINON WATER BOTTLE CAP Back to Search Results
Model Number 00711553
Device Problem Fluid Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/31/2017
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. " device not returned to manufacturer.
 
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.
 
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Brand NameAQUSHIELD SYSTEM CO2 - FUJINON
Type of DeviceWATER 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 Key6817349
MDR Text Key83747850
Report Number1528319-2017-00023
Device Sequence Number1
Product Code FEQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K163424
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
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 Received08/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/25/2018
Device Model Number00711553
Device Catalogue Number00711553
Device Lot Number1708707
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/31/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/25/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/24/2017 Patient Sequence Number: 1
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