MAUDE Adverse Event Report: MEDIVATORS, INC. ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM

Model Number 1-2-510.003

Device Problem Fluid/Blood Leak (1250)

Patient Problem Eye Pain (4467)

Event Date 02/16/2022

Event Type  malfunction  

Event Description

The user facility reported that an employee was servicing their advantage plus endoscope reprocessing system for a fluid leak detected warning error and disconnected the water sanitize line.As they disconnected the line, the employee was splashed in the face.The employee flushed their eye with water for 15 minutes and returned to work.

Manufacturer Narrative

The employee subject of the event was not wearing proper ppe, specifically, eye protection while servicing the unit.The advantage plus endoscope reprocessing system user manual states (20), "warning: avoid possible chemical burns.Wear personal protective equipment (clothing, mask, gloves and eye wear)." the user manual further states (63), "service: if leaking fluids are present, contact a qualified service technician." the unit was installed in 2014 and is not under medivators service agreement for maintenance activities.Medivators has attempted to contact the user facility for additional information regarding the status of the unit; however, to date the user facility has not responded.No additional issues have been reported.

• Brand Name: ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM
• Type of Device: ENDOSCOPE REPROCESSING SYSTEM
• Manufacturer (Section D): MEDIVATORS, INC.; 14605 28th avenue n; plymouth MN 55447
• Manufacturer (Section G): MEDIVATORS, INC.; 14605 28th avenue n; plymouth MN 55447
• Manufacturer Contact: daniel davy ; 9800 59th avenue n; plymouth, MN 55442 ; 4403927453
• MDR Report Key: 13801226
• MDR Text Key: 297224637
• Report Number: 2150060-2022-00012
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1-2-510.003
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2022
• Date Device Manufactured: 11/18/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1