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

Model Number	DSD EDGE 120V
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	09/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that an employee experienced a burn after contacting liquid remaining in their dsd edge endoscope reprocessing system.No medical treatment was sought or administered, and the employee continued working.
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the unit and found the unit to be operating according to specification.The reported event could not be duplicated, and no repairs to the unit were made.However, as the unit was still under warranty, the user facility requested a replacement unit.The unit has been replaced.The user facility employee was not wearing proper ppe, specifically gloves, at the time of the reported event.The dsd edge aer instructions for use (pg.30) states, "warning! avoid possible chemical burns.Always wear personal protective equipment (gloves, goggles) when handling disinfectant." a steris account manager counseled user facility personnel on the proper use of the dsd edge endoscope reprocessing system, including the importance of wearing proper ppe.No additional issues have been reported.

• Brand Name: DSD EDGE ENDOSCOPE REPROCESSING SYSTEM
• Common Device Name: DSD EDGE REPROCESSING SYSTEM
• Manufacturer (Section D): MEDIVATORS INC.; 14605 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS INC.; 14605 28th ave n; minneapolis MN 55447
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 20484871
• Report Number: 2150060-2024-00054
• Device Sequence Number: 11651125
• Product Code: FEB
• UDI-Device Identifier: 00677964046674
• UDI-Public: (01)00677964046674(11)231117
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 10/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: DSD EDGE 120V
• Device Catalogue Number: DSD3008
• 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: 09/19/2024
• Initial Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2023
• 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