MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 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	01/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris account manager arrived onsite to investigate the reported event.The account manager found the table to be operating properly; no repairs were required.The table operated as designed to not respond to the level command while in reverse orientation.The 5085 surgical table operator manual states (5-19), "important: when using the reverse patient touch pad, note the following: when operating in reverse orientation, level function does not operate." the account manager performed in-service training on the proper use and operation of the 5085 surgical table, specifically that the level function does not operate when the table is in reverse orientation.No additional issues have been reported.
Event or Problem Description
The user facility reported that at the end of a patient procedure with their 5085 surgical table in reverse trendelenburg the table would not return to level as commanded on the hand control.User facility personnel manually transferred the patient to a stretcher.No report of injury.

• 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 ; 4403927453
• MDR Report Key: 16397376
• Report Number: 1043572-2023-00039
• Device Sequence Number: 6602152
• Product Code: FQO
• UDI-Device Identifier: 00724995154905
• UDI-Public: 00724995154905
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 02/17/2023

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: 01/23/2023
• Initial Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2020
• 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