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

Model Number 1-2-510.003

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/05/2022

Event Type  malfunction  

Manufacturer Narrative

A medivators account manager was informed by user facility personnel that on multiple occasions, their processing cycles were not successfully completed, and the user facility continued to use the scopes during patient procedures.The errors for the failed cycles were reviewed by the account manager and indicated that the hookups were not pressurized or not connected.This is indicative of user facility personnel not properly attaching the hookups to the scopes.The advantage plus aer operator manual states (20), "warning summary if a run error was generated, a channel is blocked, or the endoscope is leaking, the endoscope must not be released for patient use.If there is any doubt as to whether an endoscope is correctly disinfected, it must be disinfected again before use.Contact your supervisor for further instructions." a steris service technician arrived onsite to inspect the aers and found the units to be operating properly.The units were returned to service.One hookup was found to be damaged and required replacement.Medivators is not aware of any adverse clinical event associated with this incident and is filing this mdr because the high-level disinfection of devices processed in the advantage plus cannot be guaranteed unless devices are processed in accordance with medivators instructions for processing and use.The user facility has indicated they will notify the patient's impacted as a result of the reported event per their internal policies and procedures.The medivators account manager performed in-service training with user facility personnel on the proper use and operation of the advantage plus, specifically not to release endoscopes for patient use when an error occurs.No additional issues have been reported.

Event Description

The user facility reported that errors were observed following processing of scopes in their advantage plus aers and the scopes were subsequently used in patient procedures.No report of injury.

• 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 n; minneapolis, MN 55447 ; 4403927453
• MDR Report Key: 16278381
• MDR Text Key: 308560541
• Report Number: 2150060-2023-00009
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2022
• 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