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

Model Number 5095 SURIGICAL TABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 05/03/2022

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the surgical table and found it to be operating properly.No issues were noted with the function or operation and the table was returned to service.User facility personnel were counseled on the proper use and operation of the table.No additional issues have been reported.

Event Description

The user facility reported that prior to the start of a patient procedure, hospital personnel were utilizing the hand control to their 5095 surgical table to command the table to slide however, the table's back section began to move side to side.Hospital personnel were able to place the table in the desired position and the procedure was completed successfully.No injury or procedure delay was reported.

Event Description

Contrary to the reported event, the patient procedure was in process.

Manufacturer Narrative

The steris service technician received confirmation from user facility personnel that at the time of the reported event the patient had been sedated.

• 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: 14577634
• MDR Text Key: 301027995
• Report Number: 1043572-2022-00042
• Device Sequence Number: 1
• Product Code: FQO
• UDI-Device Identifier: 00724995195625
• UDI-Public: 00724995195625
• 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: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5095 SURIGICAL TABLE
• Device Catalogue Number: ST015211000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2021
• 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