MAUDE Adverse Event Report: STERIS CORPORATION STERIS; 5095 SURGICAL TABLE

Model Number	5095 SURGICAL TABLE
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
User facility personnel stated that the patient sustained a "poke" from the grasper instrument that was being utilized during the time of the reported event.The patient received an x-ray.A steris service technician arrived onsite following the reported event to inspect the 5095 surgical table.The technician found no issues with the function or operation of the table and confirmed it to be operating to specifications.The technician observed a dent to the table base cover.User facility personnel stated to the technician that the table had contacted a stool that was positioned adjacent to the table when it "abruptly dropped".During the technician's inspection, he found that at the time of the reported event, the table had contacted an obstruction (another table) during hand control commands.When the tabletop became obstructed, user facility personnel continued commands via the hand control which caused the table base to lift from the floor.When the obstruction became dislodged the table base fell back to the floor subsequently causing the uncommanded movement and "loud noise".The 5095 operator manual states, "warning, personal injury and/or equipment damage hazard: failure to keep all personnel and equipment clear of the surgical table before actuating any inertia-driven or power-driven movement could result in table damage and/or personal injury".Steris offered in-service training on the proper use and operation of the device, specifically the importance of having equipment clear of the surgical table however, the user facility declined.The technician returned the table to service, and no additional issues have been reported.
Event or Problem Description
The user facility reported that during a patient procedure, their 5095 surgical table was in reverse trendelenburg position, when the foot end of the table "abruptly dropped down" causing the head section to rise upwards.User facility personnel stated a "loud noise" was heard during the movement.User facility personnel elected to cancel the procedure.

• Brand Name: STERIS
• Common Device Name: 5095 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: 23863112
• Report Number: 1043572-2025-00122
• Device Sequence Number: 18479170
• Product Code: FQO
• UDI-Device Identifier: 00724995195649
• UDI-Public: (01)00724995195649(11)250326
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• 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): 12/22/2025

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: 5095 SURGICAL TABLE
• Device Catalogue Number: ST015211002
• 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: 11/26/2025
• Initial Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2025
• 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 Number: 1
• Patient Sex: Unknown