MAUDE Adverse Event Report: MEDIVATORS INC. ENDOGATOR; ENDOSCOPIC IRRIGATION/SUCTION SYSTEM

Model Number	100241
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
During numerous endoscopy's, the "endogator single use auxiliary water jet connector" that was connected to olympus gastroenterology endoscopes either broke off completely or began to leak while they were using the water jet.I talked to ambulatory care center (acc) nurses, and they said, between their unit and the operating room, over the last 4 to 6 weeks or so, they have had about a dozen of the endogator water jet connectors either fail or break.When the connectors would fail without breaking off, they would leak between the small seal and a connecting piece of plastic, causing limited water to be used in the cleaning process during the endoscopy.If the connector completely broke off, the procedure would need to be stopped until the broken piece could be replaced.

• Brand Name: ENDOGATOR
• Common Device Name: ENDOSCOPIC IRRIGATION/SUCTION SYSTEM
• Manufacturer (Section D): MEDIVATORS INC.; 14605 28th avenue north; minneapolis MN 55447
• MDR Report Key: 9646658
• Report Number: 9646658
• Device Sequence Number: 19525012
• Product Code: OCX
• UDI-Device Identifier: 00677964058486
• UDI-Public: (01)00677964058486
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/22/2020
• Report Date (Section F): 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 100241
• Device Catalogue Number: 100241
• Device Lot Number: 440895
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/30/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/23/2020