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

Device Problem Leak/Splash (1354)

Patient Problem Headache (1880)

Event Date 01/04/2024

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived on site to inspect the unit and found the barb fitting part broke, which is a fitting that connects the silicone hose coming from the single shot generator to the dosing valve for rapicide part a, which led to the leak.The unit was installed in 2014 making it approximately 10 years old.The technician replaced the barb fitting, tested the unit, confirmed it to be operational, and returned it to service.No additional issues have been reported.

Event Description

The user facility reported that rapicide disinfectant was leaking from their dsd edge endoscope reprocessing system.It has been reported that user facility personnel in the room with the unit experienced inhalation/irritation effects.The employees received medical treatment and their symptoms have resolved.

• 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 ; 4403927453
• MDR Report Key: 18626275
• MDR Text Key: 334627835
• Report Number: 2150060-2024-00007
• 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: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2014
• 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