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

Model Number	1-2.610.002
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	02/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported via vigilance report to bfarm that as an employee was unloading their advantage plus pass-thru endoscope reprocessing system the door contacted the employees arm resulting in two bruises.The employee returned to work.
Additional Manufacturer Narrative
A medivators service technician was dispatched to perform an inspection of the unit.The investigation into the reported event is in process.A follow-up report will be submitted when additional information becomes available.
Additional Manufacturer Narrative
A cantel service technician arrived onsite to inspect the unit and found the door was pushed out of the guide rail.While onsite, the technician spoke with user facility personnel who reported the door was pushed out of the guide rail as a result of the employee removing their arm from the unit at the time of the event.The technician made the necessary adjustments to the door.The technician tested the unit following the adjustments and was unable to duplicate the reported event.No issues with the function or operation of the door were identified and the unit was returned to service.Based on the technician's inspection, the cause of the door closing as reported by the user facility could not be determined.The door is opened and closed utilizing a foot switch on the bottom of the unit.The door is equipped with a sensor that will automatically reopen the door after 5 seconds if an obstruction occurs.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; 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: 13698353
• Report Number: 2150060-2022-00010
• Device Sequence Number: 5333463
• Product Code: FEB
• UDI-Device Identifier: 00677964095832
• UDI-Public: 00677964095832
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/08/2022

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
• Operator of Device: Health Professional
• Device Model Number: 1-2.610.002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2022
• Supplement Date Received by Manufacturer: 02/21/2022; 02/21/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 05/07/2022; 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2020
• 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