MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 4085 SURGICAL TABLE

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/06/2019

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the 4085 surgical table and found that the table was leaking hydraulic oil and the leg section would not operate correctly.The technician found that a banjo bolt within the surgical table had broken in half.The banjo bolt connects the hydraulic oil hose to the table's leg cylinder and allows the oil to flow between the two parts.When the bolt broke it caused the oil to leak out and the reported event to occur.Upon further inspection, the technician found the root cause of the reported event to be attributed to the set screw that holds the leg cylinder in place.The set screw was loose which caused the leg cylinder to move out of position.This allowed excess pressure to be placed on the banjo bolt causing it to break.The technician replaced the leg cylinder and banjo bolt, tightened the set screw, tested the surgical table and found it to be operating according to specification.No additional issues have been reported.

Event Description

The user facility reported their 4085 surgical table began leaking oil during a patient procedure.The patient was transferred to a different surgical table and the procedure was completed successfully.No report of injury.

• Brand Name: 4085 SURGICAL TABLE
• Type of Device: 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: 9417852
• MDR Text Key: 208324961
• Report Number: 1043572-2019-00099
• 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: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• 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: 11/06/2019
• 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