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

Model Number 1-2.610.002

Device Problem Insufficient Information (3190)

Patient Problem Bruise/Contusion (1754)

Event Date 02/18/2022

Event Type  malfunction  

Event 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.

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.

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
• 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: 13698353
• MDR Text Key: 289081531
• Report Number: 2150060-2022-00010
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964095832
• UDI-Public: 00677964095832
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 1-2.610.002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/21/2022
• Initial Date FDA Received: 03/08/2022
• Supplement Dates Manufacturer Received: 02/21/2022; 02/21/2022
• Supplement Dates FDA Received: 05/07/2022; 09/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2020
• 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