MAUDE Adverse Event Report: MEDIVATORS INC DSD EDGE AUTOMATED ENDOSCOPE REPROCESSOR

Device Problem Smoking (1585)

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

Event Date 03/04/2023

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the unit and found that the internal drain line was damaged and leaked onto the ground fault interrupter outlet (gfi).As the drain line leaked onto the gfi, the gfi sustained electrical damage resulting in the reported event.The dsd edge automated endoscope reprocessor is not under steris service agreement for maintenance activities.The user facility is responsible for all maintenance activities.This unit was installed in 2011 making it approximately 12 years old at the time of the reported event.The technician counseled user facility personnel on the importance of following proper preventive maintenance activities.The unit has been removed from service.Due to the damage sustained, steris is working to provide the customer a quote for a new unit.No additional issues have been reported.

Event Description

The user facility reported that they heard a "pop" noise and observed smoke emitting from their dsd edge automated endoscope reprocessor.No report of injury.

• Brand Name: DSD EDGE AUTOMATED ENDOSCOPE REPROCESSOR
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• 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 ; 9800 59th avenue n; plymouth, MN 55442 ; 4403927453
• MDR Report Key: 16638185
• MDR Text Key: 312314665
• Report Number: 2150060-2023-00018
• 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
• Type of Report: Initial
• Report Date: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2011
• 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