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

Model Number DSD EDGE

Device Problems Break (1069); Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591); Gas/Air Leak (2946)

Patient Problem Insufficient Information (4580)

Event Date 07/28/2020

Event Type  malfunction  

Event Description

Multiple errors on unit, broken back flow sensor leaks water and air leaks.The endoscope was removed and reprocessed on a different disinfector.No errors on other reprocessor.

• 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: 10520556
• MDR Text Key: 206511007
• Report Number: 10520556
• 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: 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DSD EDGE
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/31/2020
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1