MAUDE Adverse Event Report: MEDIVATORS ENDOGATOR AUXILIARY WATER JET CONNECTOR

Model Number	100310
Medical Device Problem Code	Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A facility reported that blood/fluid backflow was observed in the irrigation pump tubing during a procedure while using medivators endogator auxiliary water jet connector.The initial report included photographic evidence of the tubing and connector involved in this incident.It is unknown if the facility replaced/switched out both the tubeset and auxilliary connector after the procedure as instructed in medivators endogator endoscopy irrigation tubing ifu.There is potential cross contamination between patient procedures.Medivators was unable to confirm if the facility was using the endogator auxiliary water jet connector with medivators endogator tubing which it is specifically intended for use with, thus potential off label use of the device.To date, there have been no reported illnesses or injuries as a result of this incident.This complaint will continue to be monitored within medivators complaint system.
Event or Problem Description
A facility reported blood/fluid backflow in the tubing to the pump during a procedure using medivators auxiliary water jet connector.There is potential for patient cross contamination.

• Brand Name: ENDOGATOR AUXILIARY WATER JET CONNECTOR
• Common Device Name: AUXILIARY WATER JET CONNECTOR
• Manufacturer (Section D): MEDIVATORS; 3150 pollok drive; conroe TX 77303
• MDR Report Key: 6839309
• Report Number: 1651395-2017-00002
• Device Sequence Number: 18842448
• Product Code: FEQ
• UDI-Device Identifier: 00677964052453
• UDI-Public: 00677964052453
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K092429
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Remedial Action: Replace,Notification,Inspection
• Type of Report: Initial
• Report Date (Section B): 09/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 04/01/2020
• Device Model Number: 100310
• Device Lot Number: 855261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2017
• Initial Report FDA Received Date: 09/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other