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

Model Number 1-2-510.003

Device Problem Smoking (1585)

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

Event Date 03/02/2022

Event Type  malfunction  

Manufacturer Narrative

Medivators has requested to perform an inspection of the unit.The user facility stated the unit is not available for inspection as it has been removed from service while the facility plumbing is being repaired.The unit was installed in 2014 and is not under medivators service agreement for maintenance activities; the user facility is responsible for all maintenance activities.A follow-up mdr will be submitted should additional information become available.

Event Description

The user facility reported that smoke was emitting from the back of their advantage plus endoscope reprocessing system.No report of injury.

Manufacturer Narrative

Following completion of the repairs to the facility plumbing, the user facility contacted medivators to perform an inspection of the advantage plus endoscope reprocessing system.A medivators service technician arrived onsite to inspect the unit and found a connection on the hard drive was burnt resulting in the reported smoke.The technician observed that the vent holes on the back of the pc were blocked.Without proper ventilation, the hard drive can begin to overheat which likely caused to damage to the hard drive connection.The advantage plus endoscope reprocessing system states (13), "do not block ventilation openings." the technician replaced the hard drive and connections, tested the unit, confirmed it to be operating according to specification, and returned it to service.The unit was installed in 2014 and is not under medivators service agreement for maintenance activities; the user facility is responsible for all maintenance activities.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; 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: 13971030
• MDR Text Key: 298136543
• Report Number: 2150060-2022-00021
• Device Sequence Number: 1
• Product Code: FEB
• 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,Followup
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 03/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2014
• 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