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

Device Problem Leak/Splash (1354)

Patient Problem Discomfort (2330)

Event Date 09/16/2022

Event Type  malfunction  

Manufacturer Narrative

A medivators service technician arrived onsite to inspect the unit and found that a basin regulator cracked causing the reported leak.The unit was installed in 2015 making it approximately 7 years old and is not under medivators service agreement; the user facility is responsible for all maintenance activities.The dsd edge operator manual states (9), "on a monthly basis (or if a leak is detected), inspect the reprocessor for basin damage or pipe and tubing damage, which may result in leaks." the technician replaced the regulator, tested the unit, confirmed it to be operating according to specification, and returned it to service.No additional issues have been reported.

Event Description

The user facility reported that their dsd edge automated endoscope reprocessor was spraying liquid onto the floor.An employee in the room at the time of the event experienced inhalation/irritation and slipped on the liquid.The employee sought medical treatment at the er.

• 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 ; 14605 28th ave n; minneapolis, MN 55447 ; 4403927453
• MDR Report Key: 15598819
• MDR Text Key: 305950043
• Report Number: 2150060-2022-00042
• 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: 10/13/2022

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: 09/16/2022
• Initial Date FDA Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2015
• 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