MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 5085 SURGICAL TABLE

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 03/01/2018

Event Type  malfunction  

Manufacturer Narrative

No report of injury, procedure delay or cancellation.Following the reported event, the 5085 surgical table was removed from service.A steris service technician arrived onsite to inspect the surgical table and hand control.The technician utilized several different hand controls as well as the table's back-up hand control system and found that the table performed properly in each instance.Additionally, the technician inspected the table and did not observe any hydraulic leaks and confirmed the table's batteries and voltage were operating according to specifications.The technician could not duplicate the reported event; no repairs were required.The 5085 surgical table was returned to service.Per discussion with user facility personnel, the technician learned that user facility personnel were not properly using the table's foot pump in conjunction with the backup hand control as stated in the table's operator manual.The 5085 surgical table operator manual states (pg.5-22), "the steris 5085 srt surgical table is equipped with a backup hand control system.This system can be actuated at any time and allows table operation in the event of primary control malfunction.A pedal (foot pump to provide hydraulic power) and backup hand control are located in the table base behind cover panel and are used for table movements." on 3/21/2018, a steris account manager provided in-service training on the proper use and operation of the 5085 surgical table and hand control.No additional issues have been reported.

Event Description

The user facility reported that at the end of a patient procedure their 5085 surgical table did not respond to hand control commands.User facility personnel tried utilizing a second hand control and the table's back-up hand control system however; the table did not respond.The procedure was completed successfully.

• Brand Name: 5085 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: 7383220
• MDR Text Key: 104041299
• Report Number: 1043572-2018-00030
• 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: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2018
• 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