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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVATORS ENDOGATOR SINGLE USE AUXILIARY WATER JET CONNECTOR FOR PENTAX GI ENDOSCOPES

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MEDIVATORS ENDOGATOR SINGLE USE AUXILIARY WATER JET CONNECTOR FOR PENTAX GI ENDOSCOPES Back to Search Results
Model Number 100242
Device Problem Fluid Leak (1250)
Patient Problem Exposure to Body Fluids (1745)
Event Date 10/25/2016
Event Type  No Answer Provided  
Manufacturer Narrative
The facility called to report that the endogator auxiliary water jet connector for pentax gi endoscopes was leaking because oring on the plastic connector that connects to the endoscope was too big. It was reported that the physician got sprayed with irrigation fluid when he activated the irrigation system. There is potential for cross contamination exposure. Medivators quality assurance team inspected the returned connectors from this lot and the issue could not be duplicated. The water that is sprayed from the connector would have been from the sterile water bottle when used in conjunction with the irrigation pump. There was no reported injury to the physician. This complaint will continue to be monitored within medivators complaint system.
 
Event Description
The case states that a single use auxiliary water jet connector for pentax endoscopes was leaking and sprayed the physician performing the procedure. There is potential for cross contamination.
 
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Brand NameENDOGATOR SINGLE USE AUXILIARY WATER JET CONNECTOR FOR PENTAX GI ENDOSCOPES
Type of DeviceAUXILIARY WATER JET CONNECTOR
Manufacturer (Section D)
MEDIVATORS
3150 pollok dr
conroe TX 77303
Manufacturer (Section G)
MEDIVATORS
3150 pollok dr
conroe TX 77303
Manufacturer Contact
megan dickey
14605 28th ave n
minneapolis, MN 55447
7635533327
MDR Report Key6123023
MDR Text Key60748487
Report Number1651395-2016-00007
Device Sequence Number1
Product Code FEQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092429
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Remedial Action Patient Monitoring
Type of Report Initial
Report Date 11/22/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/22/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number100242
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2016
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/25/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/03/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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