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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DSD EDGE ENDOSCOPE REPROCESSING SYSTEM
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DSD EDGE ENDOSCOPE REPROCESSING SYSTEM Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Insufficient Information (4580)
Event Date 01/17/2024
Event Type  malfunction  
Manufacturer Narrative
A steris technician arrived onsite to inspect the dsd edge endoscope reprocessing system.The technician ran test cycles and was unable to duplicate the reported event.No issues were found with the function or operation of the unit; the unit was returned to service.The customer informed the steris technician that the door to the scope room was closed while the dsd edge endoscope reprocessing system was running, potentially attributing to the odor.A follow-up mdr will be submitted should additional information become available.No additional issues have been reported.
 
Event Description
The user facility reported an "acidic odor" making personnel dizzy in the scope room where their dsd edge endoscope reprocessing system is located.It was not provided whether medical treatment was sought or administered.
 
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Brand Name
DSD EDGE ENDOSCOPE REPROCESSING SYSTEM
Type of Device
ENDOSCOPE REPROCESSING SYSTEM
MDR Report Key18715047
MDR Text Key336545764
Report Number2150060-2024-00009
Device Sequence Number1
Product Code FEB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Type of Report Initial
Report Date 02/15/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/17/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/05/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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