MAUDE Adverse Event Report: STERIS CORPORATION STERIS; SURGICAL TABLE

Model Number	5095 SURIGICAL TABLE
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived on site to inspect the 5095 surgical table.The technician discussed the reported event with user facility personnel who stated that the 5095 surgical table was commanded to reverse trendelenburg position with the patient in reverse orientation.Following this commanded, staff heard a "popping" noise and observed hydraulic fluid to be leaking.User facility personnel stated that the table contacted the floor or an object on the base of the table during the time of the event.The steris service technician inspected the 5095 surgical table and found that the hydraulic hose was disconnected from the banjo bolt.The technician further inspected the table and found that the banjo bolt head that resides underneath the leg-section was sheared off.This occurred because of the table's contact and attempted movement while in contact with an external fixed object.The steris 5095 surgical table operator manual states (pg.9), "do not store items on surgical table base.Doing so may result in equipment damage or inadvertent tabletop movement placing the patient and/or user at risk of injury.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." the technician repaired the 5095 surgical table, tested the table, found it to be operating according to specification, and returned it to service.The steris representatives offered in-service training on the als collision, software function, and the correct usage of the table related to different pt orientation.The user facility accepted, and the in-service is scheduled to occur on july 31, 2024.No additional issues have been reported.
Event or Problem Description
The user facility reported that at the conclusion of a patient procedure it was observed that hydraulic fluid was leaking from their 5095 surgical table.The patient procedure was completed successfully however, the following procedure was delayed.No report of injury.

• 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
• MDR Report Key: 19829375
• Report Number: 1043572-2024-00051
• Device Sequence Number: 7421105
• Product Code: FQO
• UDI-Device Identifier: 00724995195649
• UDI-Public: (01)00724995195649
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/25/2024

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 SURIGICAL 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: 06/27/2024
• Initial Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2024
• 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