MAUDE Adverse Event Report: STERIS CORPORATION AMSCO; 3085 SP SURGICAL TABLE

Model Number	3085 SP SURGICAL TABLE
Medical Device Problem Code	Device Tipped Over (2589)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure their 3085 surgical table "tipped over" resulting in a procedure postponement.The patient was uninjured, but employees suffered minor injuries while stabilizing the patient back onto the table.It is unknown at this time whether medical treatment was sought or administered.
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the surgical table and found no issues with the function or operation of the table.The reported event could not be duplicated.The exact cause of the reported event could not be determined.The unit was tested, confirmed to be operating according to specifications, and returned to service.No additional issues have been reported.

• Brand Name: AMSCO
• Common Device Name: 3085 SP SURGICAL TABLE
• Manufacturer (Section D): STERIS CORPORATION; 2720 gunter park drive east; montgomery 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: 23563851
• Report Number: 1043572-2025-00103
• Device Sequence Number: 10123233
• Product Code: FQO
• UDI-Device Identifier: 00724995155049
• UDI-Public: (01)00724995155049(11)190805
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K971307
• 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): 11/15/2025

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: 3085 SP SURGICAL TABLE
• Device Catalogue Number: ST010101
• 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: 10/17/2025
• Initial Report FDA Received Date: 11/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2019
• 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