MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY OT1100 SURGICAL TABLE

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 06/02/2016

Event Type  No Answer Provided  

Manufacturer Narrative

A steris service technician arrived at the facility following the event and inspected the ot1100 surgical table including the gross traction mechanism.The table was installed at the customer's facility in (b)(6) of 2014.The table is not under a steris service contract and is maintained by the user facility's biomedical department.The technician's evaluation found that the gross traction locking mechanism had loosened causing the device to improperly operate during the procedure.The ot1100 surgical table has been in use at the customer's location for over two years.A review of steris complaints indicates that this is an isolated occurrence, steris has not received any additional complaints regarding the reported issue with the gross traction locking mechanism.Steris will continue to work with the customer and biomedical department to ensure the tables remain in proper working condition and additional training is provided to the surgical staff and biomedical technicians when requested.

Event Description

The user facility reported that the gross traction locking mechanism did not operate as designed during a patient procedure.The procedure was successfully completed by the surgical staff.No injuries to patient or staff were reported.

• Brand Name: OT1100 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: 5762913
• MDR Text Key: 49297647
• Report Number: 1043572-2016-00057
• Device Sequence Number: 1
• Product Code: JEA
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 06/30/2016

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: 06/02/2016
• Initial Date FDA Received: 06/30/2016
• 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