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

Lot Number 0412321018

Device Problem Unintended Movement (3026)

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

Event Date 11/22/2021

Event Type  malfunction  

Event Description

The user facility reported that during a patient procedure the foot end of their 5085 surgical table lifted off of the floor as the table was being moved into reverse trendelenberg position.The procedure was completed successfully.No report of injury or procedure delay.

Manufacturer Narrative

A steris service technician arrived onsite to inspect the 5085 surgical table and found the table to be operating properly.No issues were noted with the function or operation of the table; no repairs were required, and the table was returned to service.The description of the reported event is indicative of some obstruction stored below the table temporarily impeding the commanded table movement.The 5085 surgical table operator manual states (1-4), "caution - possible equipment damage: failure to keep all personnel and equipment clear of the table before articulation could result in table damage." a steris account manager will offer in-service on the proper use and operation of the 5085 surgical table, specifically to ensure the table is clear of any potential obstructions.A follow-up mdr will be submitted when additional information becomes available.

Manufacturer Narrative

A steris account manager offered in-service on the proper use and operation of the 5085 surgical table, specifically to ensure the table is clear of any potential obstructions; however, the user facility declined.No additional issues have been reported.

• Brand Name: 5085 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 ; 4403927453
• MDR Report Key: 13046322
• MDR Text Key: 285838744
• Report Number: 1043572-2021-00090
• 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,Followup,Followup
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 0412321018
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2021
• 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