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

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 04/25/2016

Event Type  No Answer Provided  

Manufacturer Narrative

No injuries were reported.The surgical table will be sent back to steris for evaluation.Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.

Event Description

The user facility reported that their surgical table was not operating properly.No report of injury.

Manufacturer Narrative

The user facility reported that the table articulated at an abnormal angle prior to the start of a patient procedure.No injury to patient or staff was reported in relation to the reported event.A steris service technician arrived at the user facility, inspected the surgical table and found that one of the table's set screws had loosened over time, allowing the pivot pin to detach from the table.The technician stated the pin and set screw could not be located anywhere in or around the table base.The technician removed the table from service for return to steris service engineering for further evaluation.An ot1200 table was provided to the facility in the interim for use.Each ot1000 series orthopedic surgical table contains four pivot pin assemblies which are comprised of a pivot pin and set screw.If the set screw is not properly installed into the pivot pin, the pin may not operate as designed, preventing the table from properly performing table articulations.In extreme situations, missing or improperly installed set screws can cause the table top to tilt at an extreme or abnormal angle during use.The issue identified with the user facility's ot1200 table was investigated by steris quality and engineering.While this was determined to be an isolated occurrence, steris has made the decision to inspect all ot1000 series surgical tables distributed to customers to ensure proper set screw installation.Steris corporation is implementing a field correction in which steris service technicians will remove and inspect each of the table's four pivot pin assemblies, verify proper set screw engagement, and reinstall the pivot pin on all affected ot1000 series orthopedic surgical tables.These inspections will be completed and monitored under steris field correction #1043572-05062016-001-c.

• 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: 5641392
• MDR Text Key: 44905668
• Report Number: 1043572-2016-00043
• 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,Followup
• Report Date: 05/09/2016

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: 04/25/2016
• Initial Date FDA Received: 05/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/19/2016
• 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