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

Model Number	5095 SURIGICAL TABLE
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure, user facility personnel commanded the 5095 surgical table to raise in height.Following the command, a loud "cracking" noise was heard.User facility personnel observed that the table's column shroud covers were damaged and elected to proceed with the procedure.The procedure was completed successfully following a minimal delay, and no injuries were reported.
Additional Manufacturer Narrative
A steris service technician inspected the 5095 surgical table and found that table's column shroud covers were separated and detached.The upper section of the column shroud covers were still attached to the column bellows however, all sections below were resting upon the table base cover.The technician further stated the column shroud covers were bent and scratched.The base cover labeling was also scratched and torn in spots.The damage found by the steris service technician can be attributed to user facility personnel placing/storing objects on the table base.The operator manual states (pg.5), "warning-personal injury and/or equipment damage hazard: do not store items on table base.Doing so may result in equipment damage or inadvertent tabletop movement placing the patient and/or user at risk of injury." the base cover label states, "warning do not store items on base personal injury hazard/equipment damage storing items on table base may result in equipment damage causing inadvertent tabletop movement placing the patient and/or user at risk of personal injury.Do not step or store items on base!" the steris service technician counseled user facility personnel on the proper use and operation of the 5095 surgical table and to specifically not place or store items on the table base.The steris service technician repaired the 5095 surgical table, tested it and confirmed it to be operational; the table was returned to service.No additional issues have been reported.
Additional Manufacturer Narrative
Udi related data quality updates only - alignment with gudid.

• Brand Name: STERIS
• Common Device Name: 5095 SURGICAL TABLE
• Manufacturer (Section D): STERIS CORPORATION; 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: 18008312
• Report Number: 1043572-2023-00154
• Device Sequence Number: 12646738
• Product Code: FQO
• UDI-Device Identifier: 00724995195632
• UDI-Public: (01)00724995195632(11)210526(21)0413721106
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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,Followup
• Report Date (Section B): 10/25/2023

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: 5095 SURIGICAL TABLE
• Device Catalogue Number: ST015221000
• 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: 09/26/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2021
• 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