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

Device Problem Device Remains Activated (1525)

Patient Problem No Code Available (3191)

Event Date 09/16/2015

Event Type  No Answer Provided  

Manufacturer Narrative

A steris service technician arrived at the user facility and was able to duplicate the reported event.The technician was informed the surgical floor may have been wet at the time of the event creating a suction effect on the floor lock foot pads.The technician met with the facility's or manager to discuss proper cleaning techniques for the 5085 surgical table and recommended the facility ensure the floor is completely dry before locking the feet to the floor.The technician replaced the floor lock foot pads, tested the table and returned the table to service.No further issues have been reported.

Event Description

The user facility reported the floor locks on their 5085 surgical table became suctioned to the floor and could not be disengaged.A patient was on the surgical table at the time of the event and required transfer to a different surgical table.A procedural delay was reported due to the event.

• 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: 5152761
• MDR Text Key: 28696635
• Report Number: 1043572-2015-00102
• Device Sequence Number: 1
• Product Code: FQO
• 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
• Report Date: 10/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2015
• 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: 09/17/2015
• 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