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

Device Problem Output Problem (3005)

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

Event Date 03/26/2021

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the surgical table.During the technicians inspection, he found evidence of fluid intrusion within the power supply.While onsite, the technician spoke with facility personnel who stated that the table had recently been used in a fluid intensive procedure.The fluid intrusion caused the power supply to short resulting in the reported event.The 4085 surgical table is designed to meet ipx4 fluid ingress standards, and the normal fit of the covers, along with the rtv sealant that is applied, will prevent fluid intrusion.In the event the amount of fluid present during the procedure exceeds the ipx4 rating, it is the user facility's responsibility to ensure the table is properly draped and/or a fluid catchment device is utilized to limit the amount of fluid that may come in contact with the 4085 surgical table.The table was installed in 2018 and is not under steris service agreement; the user facility's third-party service provider is responsible for all maintenance activities.The 4085 surgical table operator manual states (5-3), "some procedures performed on table mattresses or pads may involve excessive fluid exposure.Be sure to drape accordingly." the technician made the necessary repairs, tested the table, confirmed it to be operating according to specifications, and returned it to service.A steris account manager offered in-service training on how to properly drape the 4085 surgical table; however, the user facility declined this offer.No additional issues have been reported.

Event Description

The user facility reported that their 4085 surgical table stopped working at the beginning of a patient procedure.The patient was transferred to a different table and 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: 11701172
• MDR Text Key: 260247963
• Report Number: 1043572-2021-00027
• 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: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• 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: 03/26/2021
• 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