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 06/17/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Investigation of this event is currently in process.A follow-up report will be submitted once additional information becomes available.

Event Description

The user facility reported that a traction boot did not operate properly.No report of injury.

Manufacturer Narrative

The patient present during the time of the reported event was transferred to another table and the procedure was completed successfully.No injuries were reported related to this event.The surgical table and traction boot have been in use at the user facility for approximately 1 ½ years however, user facility personnel disclosed that the table is not utilized on a regular basis.Based on the information that steris has received to date from the user facility regarding the reported event, it appears that the root cause may be attributed to improper use of the product by facility personnel, specifically, not properly securing the patient's foot in the boot.Following the reported event steris sales and service personnel arrived at the user facility to inspect the surgical table.To date, the user facility has declined our numerous attempts to schedule an inspection of the equipment subject of the reported event.Additionally, a steris business development manager has made multiple attempts to obtain information regarding the reported event however; the user facility will not disclose additional information or grant steris access to inspect the surgical table.Steris offered to provide additional in-service training regarding the proper use and operation of the traction boot however; the user facility has declined the offer.

• 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: 5816678
• MDR Text Key: 50289121
• Report Number: 1043572-2016-00061
• Device Sequence Number: 1
• Product Code: JEA
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 07/22/2016

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/24/2016
• Initial Date FDA Received: 07/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/16/2016
• 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