MAUDE Adverse Event Report: MEDIVATORS INC DSD EDGE ENDOSCOPE REPROCESSING SYSTEM

Device Problem Smoking (1585)

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

Event Date 04/13/2023

Event Type  malfunction  

Manufacturer Narrative

The biomed technician removed the dsd edge aer from service for further inspection.The biomed technician inspected the unit and indicated there may have been a leak on the connection from the overflow drain or on one of the 3-point elbow connections.The internal leak may have leaked onto the ground fault interrupter outlet (gfi) subsequently causing the gfi to sustain electrical damage resulting in the reported event.The biomed technician contacted a steris service technician to obtain replacement part/component information however, due to the damage the unit sustained the user facility may choose to not make applicable repairs and remove the unit from use.The dsd edge automated endoscope reprocessor is not under steris service agreement for maintenance activities.The user facility is responsible for all maintenance activities.The dsd edge aer is approximately 11 years old.A follow-up report will be submitted should additional information become available.

Event Description

The user facility reported that their dsd edge automated endoscope preprocessor (aer) was not operating properly.User facility personnel shut down the power to the unit and dispatched their biomed technician.The biomed technician arrived and observed smoke emitting from the unit.No report of injury.

• Brand Name: DSD EDGE 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
• MDR Report Key: 16918059
• MDR Text Key: 315072349
• Report Number: 2150060-2023-00029
• 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
• Report Date: 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• 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
• Date Manufacturer Received: 04/13/2023
• Date Device Manufactured: 05/23/2012
• 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