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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CORPORATION STERIS; SURGICAL TABLE

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STERIS CORPORATION STERIS; SURGICAL TABLE Back to Search Results
Model Number 4095 SURIGICAL TABLE
Medical Device Problem Code Unintended Movement (3026)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 01/30/2026
Type of Reportable Event Malfunction
Event or Problem Description
The user facility reported that during a patient procedure, the head section of their steris 4095 surgical table began to tilt down without being commanded to do so.No report of injury.
 
Additional Manufacturer Narrative
The investigation of the reported event is in progress.A follow-up report will be submitted when additional information becomes available.
 
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Brand Name
STERIS
Common Device Name
SURGICAL TABLE
Manufacturer (Section D)
STERIS CORPORATION
2720 gunter park drive east
montgomery AL 36109
Manufacturer (Section G)
STERIS CORPORATION
2720 gunter park drive east
montgomery AL 36109
Manufacturer Contact
daniel davy
5960 heisley road
mentor, OH 44060
4402597401
MDR Report Key24632259
Report Number1043572-2026-00027
Device Sequence Number9014881
Product Code FQO
UDI-Device Identifier00724995195236
UDI-Public(01)00724995195236(11)250728
Combination Product (Y/N)N
Initial Reporter StateWA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source User Facility
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 03/18/2026
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 Number4095 SURIGICAL TABLE
Device Catalogue NumberST013911002
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 01/30/2026
Supplement Date Received by ManufacturerNot provided
Initial Report FDA Received Date03/18/2026
Supplement Report FDA Received Date06/05/2026
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured07/28/2025
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 Number1
Patient SexUnknown
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