MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 5085 SURGICAL TABLE

Model Number	5085 SURGICAL TABLE
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2019, steris was contacted by the customer in regard to their service needs for their 5085 surgical table tilting.The same day, a steris service technician arrived onsite to inspect the table and found it to be operating properly; no repairs were required.The technician was unable to duplicate the reported tilting and the table was returned to service.At that time, steris was not informed of any patient involvement related to the service request.On (b)(6) 2023, steris received the user facility medwatch subject of this event which was our first awareness of the adverse incident.Based on the technician's inspection and the description of the event, steris was unable to duplicate or determine a cause of the reported event.However, it is likely that user facility personnel inadvertently activated the tilt command on the table hand control resulting in the reported event.The table subject of the event is under steris service agreement for maintenance activities.Steris has continued to perform biannual preventive maintenance visits for the table since the reported event.The most recent preventive maintenance visit was completed on (b)(6) 2023; following the visit the table was tested and confirmed to be operating according to specification.No additional issues have been reported.
Event or Problem Description
The user facility reported via medwatch # that during a patient procedure their 5085 surgical table unexpectedly rotated left without being commanded to do so.The patient was caught by user facility personnel and eased down to the floor without any impact.The patient was transferred to another table and the procedure was completed successfully.No report of injury.
Additional Manufacturer Narrative
The date of event was (b)(6) 2019, not (b)(6) 2019.This was a typographical error in the initial report.

• Brand Name: 5085 SURGICAL TABLE
• Common Device Name: SURGICAL TABLE
• Manufacturer (Section D): STERIS CORPORATION - MONTGOMERY; 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: 17003663
• Report Number: 1043572-2023-00110
• Device Sequence Number: 6286177
• Product Code: FQO
• UDI-Device Identifier: 00724995154905
• UDI-Public: 00724995154905
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 05/25/2023

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: ST014107
• 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: 04/27/2023
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2013
• 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