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

Model Number 10241

Device Problem Break (1069)

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

Event Date 08/16/2019

Event Type  malfunction  

Event Description

Medivators endogater auxiliary waterjet connectors are falling apart.

• Brand Name: MEDIVATOR ENDOGATER
• Type of Device: ENDOSCOPIC IRRIGATION / SUCTION SYSTEM
• Manufacturer (Section D): MEDIVATORS INC.
• MDR Report Key: 8936162
• MDR Text Key: 155988261
• Report Number: MW5089357
• Device Sequence Number: 1
• Product Code: OCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/22/2019
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10241
• Device Lot Number: 419075
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1