MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 4095 SURGICAL TABLE

Device Problem Unintended System Motion (1430)

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

Event Date 09/13/2021

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the table and was able to duplicate the reported drift.The technician will replace the hydraulic trend cylinder and the cylinder will be returned to steris for evaluation.A follow-up mdr will be submitted when additional information becomes available.

Event Description

The user facility reported that during a patient procedure their 4095 surgical table drifted into trendelenburg.The procedure was completed successfully.No report of injury or procedure delay.

Manufacturer Narrative

Upon further evaluation with steris engineering, it was determined that the drift was caused by a loss in hydraulic pressure as the table had sat idle for an extended period of time, approximately one month per user facility personnel.If this occurs, it can be resolved by re-energizing the hydraulic system by turning on the hand control and repeating the desired movement/articulation.Therefore, it was determined that the table was operating properly, and the hydraulic trend cylinder did not require replacement.Through follow-up with user facility personnel, the technician learned that in addition to the reported drift the patient began to slide off of their 4095 surgical table when the tabletop was tilted.User facility personnel caught the patient.The user facility reported that their investigation determined the patient was not properly restrained resulting in the reported event.The 4095 surgical table operator manual states (1-2), "warning - personal injury hazard: failure to keep the patient properly secured with the patient safety straps at all times could result in death or serious injury.Patient must be secured to the table in accordance with recommended positioning practices.Unanticipated patient or table movement could result in death or serious injury." the table has been confirmed to be operating according to specification and returned to service.No additional issues have been reported.

• Brand Name: 4095 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: 12591517
• MDR Text Key: 275216176
• Report Number: 1043572-2021-00073
• 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
• Report Date: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2020
• 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