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

Device Problem Fire (1245)

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

Event Date 02/09/2024

Event Type  malfunction  

Event Description

The user facility reported that the compressor to their advantage plus endoscope reprocessing system caught fire.No report of injury.

Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the unit and found that the compressor was damaged.The technician replaced the compressor, tested the unit, confirmed it to be operating according to specification and returned the unit to service.The compressor subject of the event was discarded and not returned for evaluation.As the device is not available for evaluation, a root cause of the reported event could not be determined.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; 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: 18861696
• MDR Text Key: 337162415
• Report Number: 2150060-2024-00015
• 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: 03/07/2024

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2024
• Initial Date FDA Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2016
• 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