BIOSHIELD BIOPSY VALVE 00711125

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-15 for BIOSHIELD BIOPSY VALVE 00711125 manufactured by United States Endoscopy Group, Inc..

Event Text Entries

[117736232] The bioshield biopsy valve is used to cover the opening to the biopsy/suction channel inlet of a gastrointestinal endoscope. The bioshield biopsy 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. Facility personnel were wearing ppe and there was no reported treatment due to contact with fluids. The device history record was reviewed and confirmed the devices were manufactured to specification. There have been no other complaints associated with this lot. 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 cover the valve. "
Patient Sequence No: 1, Text Type: N, H10


[117736233] The distributor in the (b)(4) received report of bodily fluid spray with resultant patient and user contact during passage of devices through bioshield biopsy valves.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1528319-2018-00023
MDR Report Key7786146
Date Received2018-08-15
Date of Report2018-08-15
Date Mfgr Received2018-07-16
Device Manufacturer Date2018-02-27
Date Added to Maude2018-08-15
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
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 NameBIOSHIELD BIOPSY VALVE
Generic NameBIOPSY VALVE
Product CodeODD
Date Received2018-08-15
Model Number00711125
Catalog Number00711125
Lot Number1802882
OperatorHEALTH PROFESSIONAL
Device Availability*
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 2018-08-15

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.