MAUDE Adverse Event Report: STERIS CORPORATION; TABLETOP PAD SETS

Model Number	TABLE PAD
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The tabletop pad sets subject of the reported events are being returned to steris for evaluation.The steris 5095 surgical table operator manual states, "to ensure prolonged use of steris mattresses and pads, abide by following cleaning instructions: inspect mattress prior to and/or after use to check for mattress integrity.Dilute all cleaners, disinfectants and germicides in accordance with manufacturers' instructions.Some cleaning agents leave a residue which can build up over time.Depending on cleaning agent, it may be necessary to rinse and wipe clean with a slightly damp cloth." the operator manual additionally states, "to install a table pad, place pad in position and firmly press associated fasteners together.To remove a table pad, gently peel or lift the pad, as applicable, to free it from the tabletop." the user facility received replacement tabletop pad sets.A steris account manager has scheduled in-service training with user facility personnel on the proper use and operation to the tabletop pad set, specifically, in appropriate cleaning techniques and installation/removal with the pads.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that during patient procedures the tabletop pad sets to their 5095 surgical tables were not staying in place when the patient was in trendelenburg.In one of the procedures, there was a report of delay due to the patient being repositioned.No report of injury.
Additional Manufacturer Narrative
Contrary to the previous report the tabletop pad sets were discarded and not returned to steris for evaluation.Through follow-up with user facility personnel it was determined the cause of the reported event was due to improper cleaning and set-up techniques with the tabletop pad sets by user facility personnel.A steris account manager conducted in-service training with user facility personnel on the proper use and operation to the tabletop pad set, specifically, in appropriate cleaning techniques and installation/removal with the pads.No additional issues have been reported.

• Brand Name: NA
• Common Device Name: TABLETOP PAD SETS
• 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: 22100842
• Report Number: 1043572-2025-00050
• Device Sequence Number: 17931245
• Product Code: LWG
• UDI-Device Identifier: 00724995156596
• UDI-Public: (01)00724995156596(11)241111
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 05/28/2025

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: TABLE PAD
• Device Catalogue Number: BF016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 09/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2024
• 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