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

Device Problems Thermal Decomposition of Device (1071); Unintended Movement (3026)

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

Event Date 12/06/2017

Event Type  malfunction  

Manufacturer Narrative

The patient was moved to a different table and the procedure was completed successfully.No injury to the patient or user was reported.The table subject of the reported event was removed from service pending evaluation from a steris service technician.A steris service technician arrived on-site, and identified that the override switch was damaged and the override switch guard was missing from the table.Because the override switch guard was missing from the table this allowed the reported damage to occur to the override switch.The technician concluded that the damaged override switch resulted in continuous activation of the table, causing the unintended movement of the table and the burning smell reported by the user facility.The table was installed at the user facility in 2004 and is not under steris contract for maintenance services, all maintenance is performed by the user facility.The 3085sp surgical table's operator manual states on page 1-2, "warning - personal injury and/or equipment damage hazard: repairs and adjustments to this equipment must be made only by fully qualified service personnel.Nonroutine maintenance performed by inexperienced, unqualified personnel or installation of unauthorized parts could cause personal injury, invalidate the warranty, or result in costly damage.Contact steris regarding service options." steris last performed service on the 3085sp surgical table subject of the reported event in 2011 when the override switch guard was installed.It is unknown when the override switch guard was removed by the user facility.The steris service technician replaced the override switch, installed a new override switch guard, tested the table, and confirmed it to be operating according to specification.The table was returned to service at the user facility.No additional issues have been reported.

Event Description

The user facility reported uncommanded table movement and a burning smell during a patient procedure.A procedure delay occurred as a result.

Manufacturer Narrative

Steris became aware of this event on 12/12/2017 and filed mdr 1043572-2018-00004 on 1/10/2018.Upon receipt of user facility medwatch on 1/23/2018 we reviewed our service history and confirmed the event described in the medwatch is the same event which was reported in mdr 1043572-2018-00004.The medwatch contained no additional information from what we previously reported.The only difference was the date in which the event occurred.Steris originally reported the event occurred on (b)(6) 2017, however within the medwatch the user facility identified the date of the event to be (b)(6) 2017.

Event Description

Medwatch received from the user facility on (b)(6) 2018.

• 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: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 7179236
• MDR Text Key: 97004128
• Report Number: 1043572-2018-00004
• 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: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• 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: 12/12/2017
• 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