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

Device Problem Failure to Read Input Signal (1581)

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

Event Date 10/25/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The user facility reported the procedure was delayed due to the replacement of the hand control by user facility personnel.A steris service technician arrived onsite to inspect the 5085 srt surgical table.During the technician's inspection, he observed the hand control to be damaged.It appeared the hand control had been dropped or crushed.The hand control experienced intermittent functionality in the tilt buttons.No issues were noted with the function or operation of the 5085 srt surgical table.The technician replaced the hand control, tested the table and confirmed it to the operational.No additional issues have been reported.During the procedure when the primary control did not respond to commands, user facility personnel did not utilize the back-up hand control as stated in the operator manual.The operator manual states, (pp.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 a cover panel and are used for table movements." steris discussed the reported event with user facility personnel regarding the location and proper operation of the back-up hand control and proper handling to avoid damage.The 5085 srt surgical table was installed in 2016 and is under steris warranty.

Event Description

The user facility reported via medwatch that during a patient procedure the hand control would not respond to commands.The hand control was replaced and the patient procedure was completed successfully.No report of injury.

• Brand Name: 5085 SRT 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: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 6297896
• MDR Text Key: 66664681
• Report Number: 1043572-2017-00006
• 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: 02/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• 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: 01/03/2017
• 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