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

Model Number	3085 SP SURGICAL TABLE
Medical Device Problem Code	Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event and found that the table battery required replacement.The technician replaced the table battery, tested the function and operation of the table and confirmed it to be operating to specifications.The 3085 surgical table was returned to service, and no additional issues have been reported.
Event or Problem Description
The user facility reported that during a patient procedure their 3085 surgical table would not respond to commands via the hand control.User facility personnel attempted to utilize another hand control however; the table would not respond to commands.User facility personnel elected to proceed with the procedure which was completed successfully.No report of injury.

• 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: 23489894
• Report Number: 1043572-2025-00098
• Device Sequence Number: 4695001
• Product Code: FQO
• UDI-Device Identifier: 00724995155049
• UDI-Public: (01)00724995155049(11)180618
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 11/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 10/07/2025
• Initial Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2018
• 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