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

Model Number	DSD EDGE 120V
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event.The technician tested the function and operation of the dsd edge endoscope reprocessing system and confirmed it to be operating to specification.No leaks were observed and the reported event could not be duplicated.The technician was advised by user facility personnel that they had recently moved their dsd edge endoscope reprocessing system to a different location in the room from where it was previously installed.The relocation may have caused the drain hose to not fully be seated subsequently causing water to leak.The operator manual states, "before moving the dsd edge reprocessor, ensure the electrical cord, drain line and water supply line are either disconnected or are appropriate lengths to accommodate the relocation of the machine.Failure to do so may result in damage to the machine." the technician proactively installed clamps on the drain hose and returned the unit to service.No additional issues have been reported.
Event or Problem Description
The user facility reported that water was leaking from their dsd edge endoscope reprocessing system and onto the floor.No report of injury.

• Brand Name: DSD EDGE ENDOSCOPE REPROCESSING SYSTEM
• Common Device Name: ENDOSCOPE REPROCESSING SYSTEM
• Manufacturer (Section D): MEDIVATORS INC; 14605 28th avenue north; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS INC; 14605 28th avenue north; minneapolis MN 55447
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4402597401
• MDR Report Key: 25318982
• Report Number: 2150060-2026-00024
• Device Sequence Number: 5254710
• Product Code: FEB
• UDI-Device Identifier: 00677964046674
• UDI-Public: (01)00677964046674(11)260320
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K092387
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/28/2026

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
• Operator of Device: Health Professional
• Device Model Number: DSD EDGE 120V
• Device Catalogue Number: DSD EDGE 120V
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown