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

Device Problem Electrical Shorting (2926)

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

Event Date 07/13/2021

Event Type  malfunction  

Manufacturer Narrative

On 08/09/2021, we received medwatch report # mw5102641 from the user facility.We reviewed our records and confirmed the report was related to the subject event.On (b)(6) 2021, a steris service technician arrived onsite to inspect the table and found evidence of fluid intrusion within the power supply.Upon further inspection, the technician also found that the table's shrouds were damaged.The damage to the shrouds allowed fluids from the ongoing procedure to enter the table base and contact the power supply causing a short resulting in the reported event.Based on the technician's inspection, the damage observed to the table's shrouds is consistent with items being stored on the base of the table.The 4085 surgical table operator manual states (1-3)," do not store items on table base.Doing so may result in equipment damage or inadvertent tabletop movement placing the patient and/or user at risk of injury." the technician made the necessary repairs, tested the unit, confirmed it was operating according to specification, and returned to service.A steris account manager performed an in-service training on (b)(6) 2021 on the proper maintenance and operation of the 4085 surgical table, specifically to not store items on the table base.No additional issues have been reported.

Event Description

The user facility reported that a burning smell and smoke were coming from their 4085 surgical table during a patient procedure.A procedure delay occurred as the user facility's engineering department came to the room and unplugged the table.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: 12307157
• MDR Text Key: 266029593
• Report Number: 1043572-2021-00059
• 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: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• 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: 07/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2012
• 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