MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 3085 SURGICAL TABLE

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 06/29/2022

Event Type  malfunction  

Manufacturer Narrative

No patient was present at the time of the reported event.User facility personnel utilized another ac power cord and the scheduled patient procedure was completed successfully.A steris service technician inspected the 3085 surgical table and found the outer insulation on the ac power cord was damaged in multiple locations.The technician installed a new ac power cord, tested the surgical table, and confirmed it to be operating according to specification.The surgical table was returned to service.The 3085 surgical table has been in use for 15 years and is not serviced or maintained by steris.The 3085 surgical table operator manual states (sec.5.2) "check all cables for damage or fraying.1x per year." steris offered the user facility in-service training on the proper use and operation of the 3085 surgical table; the facility accepted this offer and is working with steris to schedule a date for this training.No additional issues have been reported.

Event Description

The user facility reported that when the ac power cord was plugged into their 3085 surgical table a blue "flame" emitted from the cord.An or staff member was present, stepped onto the flame and extinguished it; no smoke was observed.No injuries were reported.

Manufacturer Narrative

Steris performed in-service training on 7/27/2022 on the importance of following proper preventive maintenance for the 3085 surgical table.No additional issues have been reported.

• Brand Name: 3085 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: 15128547
• MDR Text Key: 302841563
• Report Number: 1043572-2022-00051
• 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: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• 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: 06/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2006
• 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