MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 5095 SURGICAL TABLE

Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that prior to the start of a patient procedure the floor locks on (b)(4) of their (b)(4) surgical tables would not disengage from the floor and in addition (b)(4) of the tables was leaking oil near the leg of the table.A 15-minute delay occurred as a result of the event.No report of injury.
Additional Manufacturer Narrative
There were three surgical tables (serial numbers: (b)(6)) subject of the reported event.A steris service technician arrived onsite to inspect the tables and found all (b)(4) surgical tables to be operating according to specifications.For the table that was leaking, the technician found the floor lock was removed and that the customer had already reattached the hydraulic line.No leak was found and the floor lock was replaced with a new one.Out of an abundance of caution, the technician did replace the floor locks for the other two surgical tables.The three surgical tables were tested, confirmed to be operational, and returned to service.Based on the description of the event and the technician's inspection, the report is likely attributed to improper cleaning practices as locking the surgical table down on wet flooring could create a vacuum seal between the floor lock feet and the flooring.The steris (b)(4) surgical table operator manual states (section 7.2), "after each weekly use of this surgical table, clean/ disinfect table as follows: 1.Perform steps 1 through 4 of after each usage.2.Check table casters and floor locks for any accumulated debris and clean as follows: a.Ensure floor locks are properly engaged (raising casters off floor).B.Hold cleaner spray can 6-8" (152-203 mm) from caster and spray cleaning fluid liberally on the caster.C.Wipe caster with a cloth, dampened with water, to remove cleaning fluid and debris.D.Perform step b and step c for remaining three casters." a steris account manager counseled the user facility personnel on proper cleaning practices.No additional issues have been reported.

• Brand Name: 5095 SURGICAL TABLE
• Common Device Name: SURGICAL TABLE
• Manufacturer (Section D): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer (Section G): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 18768382
• Report Number: 1043572-2024-00014
• Device Sequence Number: 7738914
• Product Code: FQO
• UDI-Device Identifier: 00724995195649
• UDI-Public: 00724995195649
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 02/23/2024

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
• 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: 01/24/2024
• Initial Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2023
• 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