MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 4085 SURGICAL TABLE

Device Problems Mechanical Problem (1384); Device Tipped Over (2589)

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

Event Date 02/03/2021

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the 4085 surgical table.The technician reviewed the table's operation log and identified that contrary to the reported event, the table was commanded to unlock by the backup hand control indicating that the table had been unlocked by user facility personnel.The 4085 surgical table operator manual states (1-1), "warning - tipping hazard: do not release floor locks while patient is on table." the technician counseled user facility personnel on the proper use and operation of the 4085 surgical table, specifically to not release the floor locks while a patient is on the table.The technician tested the table, confirmed it to be operating properly, and returned it to service.No additional issues have been reported.

Event Description

The user facility reported that during a patient procedure their 4085 surgical table unlocked without being commanded to do so and began to tip.User facility personnel caught the table and secured the patient.The procedure was completed successfully.No report of injury.

• Brand Name: 4085 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: 11407470
• MDR Text Key: 254833095
• Report Number: 1043572-2021-00011
• 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: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2021
• 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: 02/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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