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

Device Problem Positioning Problem (3009)

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

Event Date 10/23/2015

Event Type  No Answer Provided  

Manufacturer Narrative

User facility personnel exchanged the table with another 3085sp table and had the same issue.The table was stabilized using stackable steps, and the procedure was completed.A delay in the procedure occurred due to the exchange in tables.No injury was reported.A steris service technician arrived on site, and found that the user facility had unlocked the table in order to put the table in the desired position for the completion of the procedure.The technician tested the table with his weight and confirmed that when the table is locked it does not tip.The technician was able to get the table to tip when it was unlocked and confirmed that no malfunction occurred.The operator manual states, "warning tipping hazard: do not place patient on the table unless floor locks are engaged." as well as "do not release floor locks while patient is on the table." the table has been returned to service and no additional issues have been reported with the table.The table is under steris contract for preventative maintenance.The technician has discussed the proper use and operation of the surgical table with the user facility.

Event Description

The user facility reported that their 3085sp surgical table was tipping during a procedure while the table was in reverse orientation.

• Brand Name: 3085SP 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: 5242954
• MDR Text Key: 32105782
• Report Number: 1043572-2015-00122
• 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: 11/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2015
• 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: 10/23/2015
• 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