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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 01/31/2017

Event Type  malfunction  

Manufacturer Narrative

The table was removed from service following the event until a user facility biomed technician could inspect the table.The 3080sp surgical table has been in service for over 22 years and is not under steris contract for preventative maintenance services.The 3080sp surgical table operator manual states on page 6-2 within the recommended preventative maintenance schedule, "check side tilt mechanism for any play and ensure screws on the top clevis and bottom support bracket are secure.2x per year." the user facility stated that during the procedure, the table began to tilt without being commanded to do so.User facility personnel articulated the table back to a level position and the patient was re-positioned properly onto the table.The patient was transported to a different table and the procedure was completed successfully.A procedure delay occurred as a result.The user facility biomed technician inspected the table and identified the set screw in the tilt cylinder required replacement.This caused the dowel pin which holds the tilt cylinder in place to become loose, resulting in the reported event.Unrelated to the reported event it was also identified that the kidney bridge was missing a pin.The biomed technician replaced the set screw and kidney bridge pin; and returned the unit to service.Steris will offer the user facility in-service training on the proper usage and recommended preventative maintenance practices for the 3080sp surgical table.No additional issues have been reported.

Event Description

The user facility reported via medwatch # (b)(4).A patient began to slide off their 3080sp surgical table during a patient procedure; no injury was reported as a result.

Manufacturer Narrative

A steris account manager completed in-service training with the user facility on the correct usage and maintenance practices for the 3080sp surgical table on (b)(6) 2017.

• 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: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 6443576
• MDR Text Key: 71466971
• Report Number: 1043572-2017-00020
• 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: 03/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 03/01/2017
• Initial Date FDA Received: 03/29/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/02/2017
• 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