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

Model Number	ADVPT3008
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that water was leaking from their advantage plus pass thru endoscope reprocessing system into the floor below.No report of injury.
Additional Manufacturer Narrative
A steris service technician inspected the advantage plus pass thru endoscope reprocessing system and found that the drain hose was out of alignment.The technician stated that the drain hose looked like it had been moved from its location subsequently causing water to splash out of the drain box and out onto the floor.During the steris technician's discussion with user facility personnel, it was stated that a user facility employee could have moved the drain hose prior to the reported event.The steris technician reinstalled the drain hose, tested the function and operation of the unit and returned it to service.The steris technician counseled user facility personnel on the importance of not moving the drain hose and to contact steris should the unit require service activity.No additional issues have been reported.

• Brand Name: ADVANTAGE PLUS PASS THRU ENDOSCOPE REPROCESSING SYSTEM
• Common Device Name: 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: 18990170
• Report Number: 2150060-2024-00023
• Device Sequence Number: 16893532
• Product Code: FEB
• UDI-Device Identifier: 00677964095832
• UDI-Public: 00677964095832
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ADVPT3008
• Device Catalogue Number: ADVPT3008
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2024
• Supplement Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown