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

Device Problem Fire (1245)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/04/2018

Event Type  malfunction  

Manufacturer Narrative

The table was immediately unplugged following the reported event.The 3085 surgical table is not under steris service agreement for maintenance activities.All maintenance activities are performed by a third-party.A steris service technician arrived onsite following the reported event to inspect the surgical table and found that the table's ac power cord and inlet plate were damaged.The technician replaced the table's ac power cord and inlet plate, tested the table, confirmed it to be operating according to specification and returned the table to service.The root cause of the reported event can be attributed to exposure to liquid from cleaning.This caused an electrical short, which caused the reported flame.The 3085 surgical table's operator manual (1-3) states: "caution: possible equipment damage: do not spray cleaning fluid into electric receptacles and avoid spraying directly onto override switches or into clearance space above column.Spray or drippage may settle onto electric circuits inside the table causing corrosion and loss of function." the 3085 surgical table was installed in 2008 and is not under steris service agreement for maintenance activities.A steris account manager will offer in-service training on the proper use and operation of the 3085 surgical table specifically, proper cleaning techniques.No additional issues have been reported.

Event Description

The user facility reported that a small flame was observed on the cord of their 3085 surgical table at the end of a patient procedure.No injury was reported, the procedure was completed successfully.

Manufacturer Narrative

On (b)(6) 2019 the technician counseled user facility personnel on the proper use and operation of the 3085 surgical table specifically, proper cleaning techniques.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: 8214572
• MDR Text Key: 132050711
• Report Number: 1043572-2019-00001
• 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: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2019
• 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: 12/04/2018
• 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