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

Model Number	DSD EDGE 120V
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility contacted steris requesting functional testing for two of their dsd edge endoscope reprocessing systems following reports of patients "becoming sick.".
Additional Manufacturer Narrative
The user facility is conducting an investigation as a follow-up to reports of patient infections.We understand the user facility is reviewing all their pre and post procedural standard operating procedures.The user facility contacted steris asking we perform an evaluation of their dsd edge endoscope reprocessing systems to rule out the equipment as a contributor to the reported event.During steris's follow up with user facility personnel, steris was informed that the water lines were not being flushed out weekly as stated in the dsd edge endoscope reprocessing system's operator manual.The operator manual states, "chemical disinfection of the water treatment (filtration) and delivery system must be performed on a weekly basis and whenever the 0.2 micron absolute bacterial retentive filter is replaced." the dsd edge endoscope reprocessing systems were installed by steris at the user facility on june 3, 2024.During install, user facility personnel received in-service training on the proper use and operation for the dsd edge endoscope reprocessing systems.The steris clinical infection prevention specialist confirmed that user facility personnel received all documentation pertaining to the operation and maintenance for the units during the training.Throughout this investigation, the user facility tested water samples from both units and performed a gram stain culture test on instruments that had recently been processed in the units, which revealed numerous gram negative rods, and other organisms.As a result of the reported contamination, the user facility has elected to permanently remove both units from service and have them replaced.

• Brand Name: DSD EDGE ENDOSCOPE REPROCESSING SYSTEM
• Common Device Name: ENDOSCOPE 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: 21107247
• Report Number: 2150060-2025-00002
• Device Sequence Number: 7947972
• Product Code: FEB
• UDI-Device Identifier: 00677964046674
• UDI-Public: (01)00677964046674(11)240417
• 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): 01/08/2025

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: 12/09/2024
• Initial Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2024
• 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