MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY OT1000 SURGICAL TABLE

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 12/29/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The user facility stated that a patient began to slide on the table when using their ot1000 surgical table.The patient subject of the reported event was moved to a different table and the procedure was completed successfully.A procedure delay occurred as a result.A steris service technician arrived on-site, inspected the table, and identified a cracked sacral rest, which caused the patient to become unstable.The technician replaced the sacral rest, tested the table, and confirmed it to be operating according to specification.Steris quality reviewed the reported event and concluded that the clean break of the sacral rest indicates that the sacral rest was damaged prior to use in the reported event.The ot1000 surgical table operator manual states on page 4-4, "warning - personal injury and/or equipment damage hazard: inspect carbon fiber spars, sacral rest and perineal posts for possible damage and wear prior to each use.Cracked or splintered surfaces may cause injury and/or not work properly." daily maintenance states, "before each use of an ot 1000 series orthopedic surgical table, visually inspect: sacral rest and perineal posts: inspect for surface cracking or splintering.Replace any damage rests and posts.Also, pay specific attention to: a.Area around hole in sacral rest where perineal post is inserted." the steris account manager provided in-service training regarding the proper usage of the ot1000 table and on proper use of the sacral rest.No additional issues have been reported with the table.

Event Description

The user facility reported their ot1000 surgical table was not operating properly.No injury was reported.

• Brand Name: OT1000 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: 6280882
• MDR Text Key: 66139275
• Report Number: 1043572-2017-00005
• 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: 01/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2017
• 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
• Date Manufacturer Received: 12/29/2016
• 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