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

Model Number 100242

Device Problem Fluid/Blood 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.

• Brand Name: ENDOGATOR SINGLE USE AUXILIARY WATER JET CONNECTOR FOR PENTAX GI ENDOSCOPES
• Type of Device: AUXILIARY 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 Key: 6123023
• MDR Text Key: 60748487
• Report Number: 1651395-2016-00007
• Device Sequence Number: 1
• Product Code: FEQ
• UDI-Device Identifier: 00677964058493
• UDI-Public: 00677964058493
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092429
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 11/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 100242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2016
• Date Manufacturer Received: 10/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1