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

Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the table and found the table to be operating according to specification.The reported event could not be duplicated, and no repairs to the table were made.Based on the description of the event and the technician's inspection, the cause of the reported event may have been caused by improper patient handling.The 5085 srt operator manual states (1.3) "warning - tipping hazard.Do not transfer patient onto or off of the surgical table unless floor locks are engaged.Center tabletop over column before transferring patient on or off of surgical table." the operator manual further states (1.6) "personal injury hazard - failure to keep the patient properly secured with the patient safety straps at all times could result in death or serious injury." a steris account manager performed in-service training with user facility personnel on the proper use and operation of the 5085 srt surgical table.The technician returned the 5085 srt surgical table to service and no additional issues have been reported.
Event or Problem Description
The user facility reported that their 5085 srt surgical tables begin to tilt during patient transfer resulting in procedure cancellation.No report of injury.

• Brand Name: 5085 SRT 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: 19529219
• Report Number: 1043572-2024-00039
• Device Sequence Number: 20753345
• Product Code: FQO
• UDI-Device Identifier: 00724995154950
• UDI-Public: 00724995154950
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 06/13/2024

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
• 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: 05/14/2024
• Initial Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2019
• 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