MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 3080RL SURGICAL TABLE

Device Problem Leak/Splash (1354)

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

Event Date 06/26/2015

Event Type  No Answer Provided  

Manufacturer Narrative

A steris field service technician arrived onsite, inspected the surgical table, and identified the shroud bracket was bent at the corner.The hydraulic hose nearest the bent bracket was sliced on the outer surface which was the source of the hydraulic leak.The technician was informed that items were present on the table base and damaged the column shroud.The shroud bent into a position which damaged the hydraulic hose causing a leak of fluid.The lack of hydraulic fluid allowed for the table to malfunction and drop as reported by the user facility.Section 1 of the maintenance manual states, "warning - personal injury and/or equipment damage hazard: storing items on table base may result in equipment damage causing inadvertent tabletop movement placing patient and/or user at risk of personal injury.Do not use table base for storage." the technician confirmed the warning label was present on the surgical table's base which states, "warning! personal injury hazard/equipment damage.Storing items on table base may result in equipment damage causing inadvertent tabletop movement placing the patient and/or user at risk of personal injury.Do not step on or store items on base!" the technician straightened the shroud bracket, replaced the hydraulic hose, and refilled the hydraulic reservoir.The table was tested, confirmed to be operating according to specifications, and returned to service.No additional issues have been reported.The technician discussed the importance of keeping the base area clear of obstructions with the user facility staff.

Event Description

The user facility reported during a patient procedure their 3080rl surgical table was leaking hydraulic fluid and the back section began to drop.The patient was transferred to another surgical table where the procedure was completed without further incident.No report of injury.A procedural delay was reported due to the patient transfer.

• Brand Name: 3080RL 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: 4931835
• MDR Text Key: 22674575
• Report Number: 1043572-2015-00067
• 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
• Report Date: 07/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2015
• 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: 06/30/2015
• 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