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

Device Problem Noise, Audible (3273)

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

Event Date 10/21/2014

Event Type  No Answer Provided  

Event Description

The user facility reported that while a patient was present on the surgical table, the table was commanded to rise in height and a loud bang was heard.

Manufacturer Narrative

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

Manufacturer Narrative

A steris service technician inspected the table and found table base shroud pieces to be bent and out of alignment.The technician removed the shrouds and found the bracket holding the shroud to the top of the table to be bent.During the technician's inspection he noted that the warning label on the base of the table had visible scratches which could be indicative of storage of items on the base of the table.The operator manual states (pp.1-3), "do not store items or step on table base.Doing so may result in equipment damage or inadvertent tabletop movement that could place the patient and/or not work properly." the technician repaired the table and returned it to service.No additional issues have been reported.

Event Description

No injuries or procedural delays or cancellations were 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: 4266702
• MDR Text Key: 16557142
• Report Number: 1043572-2014-00120
• Device Sequence Number: 1
• Product Code: JEA
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 11/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2014
• 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: 10/21/2014
• 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