MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY OT1200 ORTHOPEDIC TABLE; SURGICAL TABLE

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 01/21/2014

Event Type  No Answer Provided  

Event Description

The user facility reported that during a patient procedure, the leg spar retention mechanism did not operate properly.No injuries were reported.A procedural delay was reported.

Manufacturer Narrative

A steris service technician arrived at the facility, evaluated the ot1200 table and found the rosette teeth which lock the leg holder into position would not unlock.The technician replaced the rosette locks and pins, tested the ot1200 table and confirmed the unit was operating to specification.The unit was installed in july of 2013 and is currently under steris warranty.The rosette locking mechanisms will be sent back to steris (b)(4) for further evaluation.Steris has confirmed this is an isolated event, however, will continue to monitor any reports related to the issue described.

• Brand Name: OT1200 ORTHOPEDIC 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: 3634529
• MDR Text Key: 3989697
• Report Number: 1043572-2014-00012
• Device Sequence Number: 1
• Product Code: JEA
• 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: 02/19/2014

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: 01/24/2014
• Initial Date FDA Received: 02/19/2014
• 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