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

Model Number 1-2-510.003

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Eye Pain (4467)

Event Date 02/22/2023

Event Type  malfunction  

Event Description

The user facility reported that following a completed cycle liquid contacted an employee's eye while removing a scope from their advantage plus aer.The employee flushed their eyes with water and sought medical treatment.

Manufacturer Narrative

A steris service technician inspected the advantage plus aer and found the device to be operating properly.The technician ran a test cycle and found no issues with the function or operation of the advantage plus aer.User facility personnel stated to the steris service technician that prior to and following the reported event, user facility personnel utilized the advantage plus aer with no issues.The employee subject of the reported event was only wearing gloves while operating the advantage plus aer.The operator manual states (pg.85), "warning: avoid possible chemical burns.Always wear personal protective equipment (gloves, goggles) when handling disinfectant and/or detergent." the steris service technician counseled user facility personnel on the proper use and operation of the advantage plus aer specifically, the importance of wearing proper ppe.The steris service technician returned the advantage plus aer to service and 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; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS INC; 14605 28th avenue n; minneapolis MN 55447
• Manufacturer Contact: daniel davy ; 9800 59th avenue n; plymouth, MN 55442 ; 4403927453
• MDR Report Key: 16592845
• MDR Text Key: 312289242
• Report Number: 2150060-2023-00017
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964044755
• UDI-Public: 00677964044755
• 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
• Type of Report: Initial
• Report Date: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2023
• 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
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2021
• 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