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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 01/17/2024

Event Type  malfunction  

Manufacturer Narrative

Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.

Event Description

The user facility reported that an employee obtained "burns" to their hands after removing endoscopes from their advantage plus endoscope reprocessing system.It is unknown if the employee sought or received medical treatment.

Event Description

The employee subject of the reported event washed their hands and applied ointment.

Manufacturer Narrative

A steris field service engineer stated that residual water and chemicals are being left under the top of the unit's lid.When the employee opened the lid to the unit the reported event occurred.The steris field service engineer stated that no issues were noted with the function or operation of the device.Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.

Manufacturer Narrative

It is unknown if the employee subject of the reported event was wearing proper ppe, specifically gloves, during the time of the reported event.The advantage plus instructions for use (ifu) states, "to avoid biological contamination and chemical burns, always wear appropriate personal protective equipment (ppe) when handling endoscopes or disinfectant solutions." the tee/toe probe instructions states, "wear chemically resistant protective gloves for hand protection when handling chemistry." the steris service technician and steris district service manager made multiple attempts to obtain additional information regarding the reported event however, 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; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS INC; 14605 28th avenue n; minneapolis MN 55447
• Manufacturer Contact: daniel davy ; 14605 28th ave north; minneapolis, MN 55447 ; 4403927453
• MDR Report Key: 18623416
• MDR Text Key: 334328892
• Report Number: 2150060-2024-00006
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2024
• Initial Date FDA Received: 02/01/2024
• Supplement Dates Manufacturer Received: 01/17/2024; Not provided
• Supplement Dates FDA Received: 03/18/2024; 04/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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