MAUDE Adverse Event Report: MEDIVATORS INC. DSD EDGE ENDOSCOPE REPROCESSING SYSTEM; ACCESSORIES, CLEANING, FOR ENDOSCOPE

Model Number DSD EDGE

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 02/18/2021

Event Type  malfunction  

Event Description

Code orange called over head for chemical spill/leak in medical procedure unit (mpu) scope room.Biomed technician called as well.Found chemical was coming from underneath the scope disinfector (dsd).Biomed technician ran a simulated scope run to find leak.Found a split in the internal tubing line on the back of the chemical tray.This line would leak when trying to pump disinfection to the basin and also drain the basin when the pump stopped.This is where the fluid on the ground came from.Biomed examined the tubing lines of our second dsd machine.Found these lines had deterioration as well.These lines are not called out to be replaced in the preventive maintenance instructions.We have replaced all tubing lines in both machines.

• Brand Name: DSD EDGE ENDOSCOPE REPROCESSING SYSTEM
• Type of Device: ACCESSORIES, CLEANING, FOR ENDOSCOPE
• Manufacturer (Section D): MEDIVATORS INC.; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 11684869
• MDR Text Key: 245995081
• Report Number: 11684869
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/29/2021

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
• Device Model Number: DSD EDGE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/29/2021
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/19/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1