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

Device Problems Sticking (1597); Device Inoperable (1663); Positioning Problem (3009)

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

Event Date 10/23/2014

Event Type  No Answer Provided  

Event Description

The user facility reported that during a patient procedure their surgical table became stuck in the left tilt position with the pump motor still running and would not respond to table commands.Another surgical table was brought in and the procedure was completed successfully.No injuries were reported however, a procedural delay was reported due to the transfer of the patient.

Manufacturer Narrative

The table subject of the reported event was removed from service.The user facility was concerned of burning because the pump motor was still running and a smell from the table was beginning to occur.Facility personnel were advised by the steris surgical service representative to press the cb2 breaker and stop battery power to the pump.The warning label on the table's column shroud states, "unanticipated table movement hazard- to remove all power from pump motor, disconnect power cord and interrupt circuit breaker (cb-2)." a steris surgical service representative inspected the table and found the override control switches to be corroded.The corrosion to the override control switches is indicative of fluid intrusion.In addition to the damaged override switches, the steris surgical service representative stated that the shrouds had evidence of impact damage from possible storage on the base.Due to the damage to the shroud, user facility personnel serviced the table by using silicon to seal the gaps between the shroud and bellows.The table was not properly sealed subsequently allowing entry points for fluid.The service representative repaired the table, tested it and returned it to service.No additional issues have been reported.While onsite the user facility was made aware of the importance of properly using rtv.The table is not under steris service contract and is serviced and maintained by the user facility.

• Brand Name: 3080-R 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: 4270633
• MDR Text Key: 5033792
• Report Number: 1043572-2014-00124
• 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: 11/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2014
• 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: 10/23/2014
• 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