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

Model Number 100241

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/10/2020

Event Type  malfunction  

Event 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
• Type of Device: ENDOSCOPIC IRRIGATION/SUCTION SYSTEM
• Manufacturer (Section D): MEDIVATORS INC.; 14605 28th avenue north; minneapolis MN 55447
• MDR Report Key: 9646658
• MDR Text Key: 176962148
• Report Number: 9646658
• Device Sequence Number: 1
• Product Code: OCX
• UDI-Device Identifier: 00677964058486
• UDI-Public: (01)00677964058486
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/23/2020,01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100241
• Device Catalogue Number: 100241
• Device Lot Number: 440895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/23/2020
• Event Location: Hospital
• Date Report to Manufacturer: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1