MAUDE Adverse Event Report: STERIS CORPORATION STERIS; 5085 SURGICAL TABLE

Model Number	5085 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	10/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the 5085 surgical table.The technician inspected the table and was unable to duplicate the reported event; no issues were found with the function or operation.As no issues were noted with the function or operation of the 5085 surgical table, the reported event may be attributed to an undetected obstruction positioned under the table.If the tabletop is commanded to lower and contacts an obstruction and the command to lower is continued, the table base could start to lift off the floor in response to the hydraulic cylinder movement.User facility personnel may visually see the table movement as suddenly lowering in height due to the obstruction becoming dislodged and the table base lifting off the floor.The 5085 surgical table operator manual states, "caution - possible equipment damage: failure to keep all personnel and equipment clear of table before articulation could result in table damage." "do not store items on table base.Doing so may result in equipment damage or inadvertent tabletop movement that could place the patient and/or user at risk of injury." the steris account manager offered in-service training on the proper use and operation for the 5085 surgical table and is awaiting a response.The reported event is attributed to user error.The steris service technician returned the 5085 surgical table to service, and no additional issues have been reported.
Event or Problem Description
The user facility reported that during a patient procedure user facility personnel commanded the foot section of their 5085 surgical table to lower in height.The foot section moved "fast/quick" to the lowest height position without being commanded to do so.User facility personnel elected to continue the patient procedure with the foot section in the undesired position.The procedure was completed successfully, and no procedure delay or injury was reported.
Additional Manufacturer Narrative
Steris offered in-service training on the proper use and operation for the 5085 surgical table; however, the user facility declined.The table has been returned to service.No additional issues have been reported.

• Brand Name: STERIS
• Common Device Name: 5085 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
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 20577650
• Report Number: 1043572-2024-00070
• Device Sequence Number: 8095395
• Product Code: FQO
• UDI-Device Identifier: 00724995154875
• UDI-Public: (01)00724995154875(11)160815
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 10/31/2024

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: 5085 SURGICAL TABLE
• Device Catalogue Number: ST014101
• 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: 10/01/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2016
• 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