MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 5095 SURGICAL TABLE

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 01/13/2022

Event Type  malfunction  

Event Description

The user facility reported that during a patient procedure with their 5095 surgical table the patient began to slide off the table.The patient was repositioned on the table.The procedure was completed successfully.No report of injury or procedure delay.

Manufacturer Narrative

A steris service technician arrived onsite to inspect the table and found it to be operating properly; no repairs were required.While onsite, the technician was informed by user facility personnel that the x-ray top was not properly secured onto the tabletop at the time of the reported event.As user facility personnel began to articulate the table, the x-ray top became unstable.The 5095 surgical table operator manual states (4-12), "4.13 installing/removing x-ray top.3.Position x-ray top section over corresponding tabletop section, aligning posts to mounting holes.4.Press down on x-ray top section until a "click" is heard.5.Ensure x-ray top sections are securely mounted by gently pulling up on section." a steris account manager performed in-service training on the proper use and operation of the 5095 surgical table, specifically properly locking the x-ray top to the table.No additional issues have been reported.

• Brand Name: 5095 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: 13508170
• MDR Text Key: 296307226
• Report Number: 1043572-2022-00012
• 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: 02/10/2022

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2022
• Initial Date FDA Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2021
• 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