MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 5085 SURGICAL TABLE

Device Problems Mechanical Problem (1384); Sticking (1597); Device Operates Differently Than Expected (2913)

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

Event Date 06/20/2014

Event Type  No Answer Provided  

Event Description

The user facility reported that at the beginning of a patient procedure they unplugged their 5085 surgical table so it could be relocated in the room.The table would not unlock via the hand control.User facility personnel utilized a back up hand control and were able to unlock the table.No injuries or procedural delays/cancellations were reported.

Manufacturer Narrative

The table subject of the reported event is being returned for evaluation.The user facility will be receiving a replacement table.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 unit and replaced the floor locks.The technician tested the unit and confirmed it was operating to specifications.However, the user facility stated the issue was still occurring intermittently.The user facility was provided a replacement table, and the table subject of the reported event was sent back to steris for evaluation.The reported event could not be duplicated by steris engineering.No issues have been reported by the facility pertaining to the replacement table.

• Brand Name: 5085 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: 4010540
• MDR Text Key: 19926271
• Report Number: 1043572-2014-00074
• Device Sequence Number: 1
• Product Code: FQO
• 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: 08/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2014
• 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: 07/15/2014
• 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