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

Model Number	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	10/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure their 5095 surgical table was commanded to lower in height and heard a "noise" from the table's shroud.The patient was transferred to a different table.No report of injury.
Additional Manufacturer Narrative
A steris service technician arrived onsite following the event to inspect the 5095 surgical table.During the technician's inspection he found damage to the table's column shroud and base.The damage observed to the table's column shroud and base are indicative of items being stored on the base of the table.When the table is commanded to lower in height, the tabletop may contact the items of the table's base subsequently causing damage.The "noise" heard by user facility personnel at the time of the reported event may also be attributed to the table contacting items on the base of the table.The 5095 operator manual states, "warning - personal injury and/or equipment damage hazard: do not store items on surgical table base.Doing so may result in table damage or inadvertent tabletop movement placing the patient and/or user at risk of injury." in addition, there is a label on the table base that 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 on or store items on base!" a steris account manager performed in-service training on the proper use and operation of the 5095 surgical table specifically the importance of not storing items on the table base.The steris technician made repairs to the 5095 surgical table, tested the function and operation of the device and returned it to service.No additional issues have been reported.

• Brand Name: STERIS
• Common Device Name: 5095 GENERAL 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: 20751365
• Report Number: 1043572-2024-00076
• Device Sequence Number: 8014011
• Product Code: FQO
• UDI-Device Identifier: 00724995195625
• UDI-Public: (01)00724995195625(11)230311
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 11/21/2024

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 SURGICAL TABLE
• Device Catalogue Number: ST015211000
• 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: 10/23/2024
• Initial Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2023
• 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