MAUDE Adverse Event Report: STERIS CORPORATION STERIS; 4085 SURGICAL TABLE

Model Number	4085 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	11/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure, user facility personnel commanded their 4085 surgical table to slide downward when they heard a "popping" sound from the powerlift beach chair to the table.User facility personnel removed the patient from the beach chair and transferred the beach chair and patient to a different surgical table resulting in a procedure delay.No report of injury.
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the beach chair and surgical table and found both to be operating according to specification.No repairs were required.While onsite, the technician observed that there was tape wrapped around the side of the table and underneath the tabletop which was blocking the surgical table's slide sensor cable.As the slide sensor cable was blocked, the surgical table did not fully respond to the downward movement command by facility personnel resulting in the reported event.The technician removed the tape from the surgical table and returned the surgical table and beach chair back to service.A steris account manager provided in-service training on the proper use of the surgical table to ensure that personnel do not place tape over the slide sensor cable.No additional issues have been reported.
Additional Manufacturer Narrative
Udi related data quality updates - alignment with gudid.The suspect medical device was also updated.

• Brand Name: STERIS
• Common Device Name: 4085 SURGICAL TABLE
• Manufacturer (Section D): STERIS CORPORATION; 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: 18369685
• Report Number: 1043572-2023-00170
• Device Sequence Number: 12704568
• Product Code: FQO
• UDI-Device Identifier: 00724995154752
• UDI-Public: (01)00724995154752(11)191111(21)0431519026
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 12/20/2023

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: 4085 SURGICAL TABLE
• Device Catalogue Number: ST013307
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2019
• 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