MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY OT 1100 ORTHOPEDIC SURGICAL TABLE

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Injury (2348)

Event Date 07/21/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Following notification of the event, a steris service technician and steris account manager visited the facility to inspect the ot 1100 orthopedic surgical table.Steris's inspection of the table concluded that all table components were operating according to specification.The traction assembly was tested through all functionalities and performed as expected; no defects or malfunctions were identified.The steris account manager was informed that the procedure being performed was an anterior approach total hip arthroplasty (aatha).The facility's or director stated that during the patient procedure, the leg spar was lowered to the floor, however the traction assembly "did not have enough slide to fully release traction".The ot 1100 traction unit assembly instructions for use contain instructions for positioning the traction unit assembly when performing anterior approach procedures such as in this event.The instructions for use state, "position traction unit assembly at optimum distance distally prior to applying traction.Ensure opposite anatomy is supported and secured.For anterior approach procedures: leave 2-3 inches at proximal end of gross traction slide mechanism." based on the facility's description of the event, it appears the gross traction assembly was not positioned in accordance with the table's instructions for use.Steris service engineering attempted to reproduce the customer's claims and concluded improper positioning of the traction assembly by facility personnel was the most likely cause of the reported event.If sufficient slide is not provided at the proximal end of the gross traction slide mechanism (2-3 inches per operator manual recommendation), the traction assembly may "not have enough slide" as reported by the facility.Steris offered additional in-service training for the facility's or staff; however, the offer has been declined.

Event Description

The user facility reported that during a patient procedure, the traction assembly on the ot 1100 surgical table did not operate according to specification.A patient injury was reported.The facility did not disclose any additional information regarding the patient's injury.

• Brand Name: OT 1100 ORTHOPEDIC 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: 5886699
• MDR Text Key: 52489777
• Report Number: 1043572-2016-00068
• 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: 08/18/2016

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: 07/21/2016
• Initial Date FDA Received: 08/18/2016
• 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