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

Device Problems Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)

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

Event Date 05/21/2015

Event Type  No Answer Provided  

Event Description

The user facility reported that while a patient was present on the surgical table, hospital personnel could not get the traction boot assembly to function properly.Hospital personnel stated the patient procedure was completed successfully.No report of injury.

Manufacturer Narrative

A steris service technician arrived onsite and was not permitted by the user facility to inspect the surgical table subject of the reported event.A review of service records indicates the reported event is the only service call to steris.The table was installed in 2014.Following the reported event the steris account manager observed how hospital personnel assembled/secured the traction boots.During his observation, hospital personnel were not assembling/securing the traction boots properly.No malfunction of the traction boots was observed.The instructions for use (traction boot assembly) states: "warning-personal injury and/or equipment damage hazard: read and understand all instructions presented in this document before using the traction boot assembly.Follow each step in the order presented in these instructions.If you need technical assistance or additional instructions, call steris." the steris account manager offered in-service training on the proper use and operation of the traction boot however, the user facility declined.The surgical table is not under steris warranty or service contract and is serviced and maintained by the user facility.

• Brand Name: OT1200 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: 4856444
• MDR Text Key: 5874120
• Report Number: 1043572-2015-00056
• 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: 06/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/21/2015
• Initial Date FDA Received: 06/19/2015
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other