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

Model Number	100242
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	10/25/2016
Additional 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 or Problem 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.

• Brand Name: ENDOGATOR SINGLE USE AUXILIARY WATER JET CONNECTOR FOR PENTAX GI ENDOSCOPES
• Common Device Name: AUXILIARY WATER JET CONNECTOR
• Manufacturer (Section D): MEDIVATORS; 3150 pollok dr; conroe TX 77303
• MDR Report Key: 6123023
• Report Number: 1651395-2016-00007
• Device Sequence Number: 19028673
• Product Code: FEQ
• UDI-Device Identifier: 00677964058493
• UDI-Public: 00677964058493
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K092429
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 11/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: 100242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2016
• Initial Report FDA Received Date: 11/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1