MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 3080SP SURGICAL TABLE

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 12/22/2017

Event Type  malfunction  

Manufacturer Narrative

The user facility stated their 3080sp surgical table's floor locks were not properly locking and the table was not moving as commanded during a patient procedure.User facility personnel were able to utilize the override switch controls on the table to move the patient to the desired position, and the procedure was completed successfully.A steris service technician arrived on-site, inspected the unit, and identified the set screw on the table's floor lock required adjustment.The technician found that because the set screw was not properly aligned, the table would not lock to the floor.This also caused the floor-lock microswitch to signal to the control board of the table that the table was not properly locked, which prevented the use of the hand control.The technician adjusted the set screw on the floor lock, tested the table, and confirmed it to be operating according to specification.The table has been in use at the facility for 22 years.The technician notified the user facility that the table must be properly locked for the table hand controls to be used.No additional issues have been reported.

Event Description

The user facility reported their 3080sp surgical table was not operating properly during a patient procedure.No injury, procedure delay, or cancellation was reported.

• Brand Name: 3080SP 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: 7206302
• MDR Text Key: 98062564
• Report Number: 1043572-2018-00007
• 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: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• 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: 12/22/2017
• 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