MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 3085 SP SURGICAL TABLE

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/18/2024

Event Type  malfunction  

Event Description

The user facility reported that during two patient procedures on separate days their 3085 sp surgical table became unlocked.There was no report of table movement during either case.User facility personnel relocked the table with the hand control and the procedures were completed successfully.No report of injury or procedure delay.

Manufacturer Narrative

A steris service technician arrived onsite to inspect the 3085 sp surgical table and found that the table's floor locks required repairs.The table was installed in 2001 making it approximately 23 years old and is not under steris service agreement; the user facility is responsible for all maintenance activities.The 3085 sp surgical operator manual states (6-1), "3.3 check floor lock system; have qualified service technician adjust if needed.6x per year" the technician made the necessary repairs to the floor locks, tested the table, confirmed it to be operating according to specification, and returned it to service.The technician counseled user facility personnel on proper preventive maintenance of their 3085 sp surgical table.No additional issues have been reported.

• Brand Name: 3085 SP SURGICAL TABLE
• Type of Device: 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: 18937240
• MDR Text Key: 338713482
• Report Number: 1043572-2024-00017
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2001
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1