BIOGUARD AIR/WATER & SUCTION VALVES KIT 00711784

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-13 for BIOGUARD AIR/WATER & SUCTION VALVES KIT 00711784 manufactured by United States Endoscopy Group, Inc..

Event Text Entries

[137832510] The valve is included within the bioguard air/water and suction kit. The 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 and provides access for irrigation. The device subject of the reported event was discarded by the user facility. 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 the valve". The device history record was reviewed and confirmed the device was manufactured to specification. There have been no other complaints associated with this lot. Us endoscopy has provided in-service training to the user facility, and no further issues have been reported.
Patient Sequence No: 1, Text Type: N, H10


[137832511] The user facility reported the lid of the biopsy valve opened, with resultant fluid spray from the device during procedural use. The fluid did not contact the user, and there was no report of harm to the patient or user.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1528319-2019-00011
MDR Report Key8337355
Date Received2019-02-13
Date of Report2019-02-13
Date Mfgr Received2019-01-14
Date Added to Maude2019-02-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. COLETTA COHARA
Manufacturer Street5976 HEISLEY RD
Manufacturer CityMENTOR OH 44060
Manufacturer CountryUS
Manufacturer Postal44060
Manufacturer Phone4403586251
Manufacturer G1UNITED STATES ENDOSCOPY GROUP, INC.
Manufacturer Street5976 HEISLEY RD
Manufacturer CityMENTOR OH 44060
Manufacturer CountryUS
Manufacturer Postal Code44060
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameBIOGUARD AIR/WATER & SUCTION VALVES KIT
Generic NameBIOPSY VALVE
Product CodeODC
Date Received2019-02-13
Model Number00711784
Catalog Number00711784
Lot Number1808083
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerUNITED STATES ENDOSCOPY GROUP, INC.
Manufacturer Address5976 HEISLEY RD MENTOR OH 44060 US 44060


Patients

Patient NumberTreatmentOutcomeDate
10 2019-02-13

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