MAUDE Adverse Event Report: STERIS CORPORATION AMSCO; SURGICAL TABLE

Model Number	3080-R
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the 3080-r surgical table and found no issues with the function or operation to the table.The reported event could not be duplicated.No repairs were required and the table was returned to service.Upon further investigation, the technician learned that user facility personnel utilized a non-steris surgical table extension accessory with the 3080-r surgical table during the procedure; specifically, to increase the table length by approximately 3-4 feet while the table was positioned in a reverse orientation.This configuration of the 3080-r surgical table and non-steris surgical table extension accessory caused the patient's body mass to go beyond the table support, subsequently resulting in the reported event.The 3080-r surgical table operator manual states the following warning to the user, "warning - instability hazard states: possible patient or user injury, as well as table or accessory failure, may result from using steris table accessories for other than their stated purpose - or from using, on steris tables, accessories manufactured and sold by other companies.".While onsite the technician counseled user facility personnel on the proper use and operation with the 3080-r surgical table, specifically, in properly using the appropriate accessories while operating the table.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.
Event or Problem Description
The user facility reported their 3080-r surgical table began to "lift" off the floor during a patient procedure.The procedure was subsequently cancelled and rescheduled.No report of injury.

• Brand Name: AMSCO
• 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 Key: 24955414
• Report Number: 1043572-2026-00037
• Device Sequence Number: 5280213
• Product Code: FQO
• UDI-Device Identifier: 00724995155018
• UDI-Public: (01)00724995155018(11)170323
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K930493
• Number of Events Summarized: 1
• 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
• Report Date (Section B): 04/22/2026

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 Number: 3080-R
• Device Catalogue Number: RC3
• 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: 03/27/2026
• Initial Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2017
• 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