MAUDE Adverse Event Report: MEDIVATORS INC DSD EDGE AUTOMATED ENDOSCOPE REPROCESSOR

Model Number	DSD Edge 120V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer is conducting an investigation as a follow-up to an "adverse reaction" that occurred to a patient post procedure.The user facility did not disclose the current patient status or if any medical treatment was administered.We understand the user facility is reviewing all their pre- and post-procedural standard operating procedures.The customer contacted steris asking we perform an evaluation of their equipment in an attempt to rule out the dsd edge aer as a contributor to the reported event.The user facility did not disclose the specific instruments that were used during the procedure subject of the reported event.A steris service technician inspected the aer and found no issues with the function or operation of the unit.The technician tested the unit, found it to be operating according to specifications and returned it to service.No additional issues have been reported.
Event or Problem Description
The user facility contacted steris, requesting functional testing of their dsd edge automated endoscope reprocessor.

• Brand Name: DSD EDGE AUTOMATED ENDOSCOPE REPROCESSOR
• Common Device Name: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS INC; 14605 28th avenue n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS INC; 14605 28th avenue n; minneapolis MN 55447
• Manufacturer Contact: daniel davy ; 14605 28th ave north; minneapolis, MN 55447 ; 4403927453
• MDR Report Key: 16683984
• Report Number: 2150060-2023-00022
• Device Sequence Number: 15450924
• Product Code: FEB
• UDI-Device Identifier: 00677964046674
• UDI-Public: 00677964046674
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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): 04/05/2023

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: 03/07/2023
• Initial Report FDA Received Date: 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2017
• 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