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

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/09/2020

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived on site to inspect the table and found there was an oil leak coming from one of the lift hydraulic cylinders.This issue is attributed to a damaged o-ring on one of the lift hydraulic cylinder pistons.The lift hydraulic cylinders o-ring required replacement resulting in the oil leak and caused the reported event to occur.The 5085 surgical table was installed in 2012 making it approximately 8 years old.The table is not under steris service agreement and all preventive maintenance is performed by a third-party service provider.The technician replaced the damaged components, tested the unit, found it to be operating to specifications, and returned it to service.A 3-year complaint review determined this to be an isolated occurrence.No additional issues have been reported.

Event Description

The user facility reported that while a patient was on their 5085 surgical table it began to leak oil and lower resulting in a procedure delay.The patient was moved to another table and the procedure was completed successfully.No report of injury.

• 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: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 10652556
• MDR Text Key: 244600705
• Report Number: 1043572-2020-00045
• 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
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• 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: 09/09/2020
• 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