MAUDE Adverse Event Report: STERIS CORPORATION; TABLE PAD

Model Number	TABLE PAD
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported via medwatch # (b)(4) that their seams are coming apart on their foot section table pad.No report of injury.
Additional Manufacturer Narrative
Through follow-up with user facility personnel and a steris account manager it was determined that the cause of the reported event was due to incompatible cleaning agents being used on the table pads.User facility personnel were utilizing an oxycide daily disinfectant cleaner that consists of hydrogen peroxide and peracetic acid.The cleaning instructions for the mattress pads and steris surgical table operator manuals states, "caution - possible equipment damage: the use of h2o2 + paa (hydrogen peroxide + peracetic acid) is strongly discouraged for use on all steris products." user facility personnel were counseled on the importance of using proper cleaning agents for their table pads and surgical tables.Steris evaluated the reported event and determined it does not meet our reporting criteria under 21 cfr part 803.It should be noted that steris is submitting a medical device report (mdr) solely due to the receipt of the user facility medwatch report which is in accordance with our procedures and policies.No additional issues have been reported.

• Brand Name: NA
• Common Device Name: TABLE PAD
• 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: 23843250
• Report Number: 1043572-2025-00119
• Device Sequence Number: 21225490
• Product Code: LWG
• UDI-Device Identifier: 00724995163877
• UDI-Public: (01)00724995163877(11)240710
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/18/2025

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: TABLE PAD
• Device Catalogue Number: BF294
• 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: 11/18/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2024
• 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