MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 3085 SURGICAL TABLE

Device Problems Self-Activation or Keying (1557); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2019

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the 3085 surgical table and found that the table bellows were not properly sealed and there was evidence of fluid intrusion on the auxiliary controls.The fluid intrusion caused the auxiliary controls to become damaged resulting in the uncommanded table movement.The reported event is attributed to improper maintenance activities as facility personnel should have ensured that the table was properly sealed.The 3085 surgical table is designed to meet ipx4 fluid ingress standards, and the normal fit of the covers, along with the rtv sealant that is applied, will prevent fluid intrusion.The table was installed in 2010 making it approximately 9 years old and is not under steris service agreement.The user facility is responsible for all maintenance activities.The 3085 surgical table operator manual (1-2) states, "warning - personal injury and/or equipment damage hazard: safe and reliable operation of this equipment requires regularly scheduled preventive maintenance, in addition to the faithful performance of routine maintenance.Contact steris to schedule preventive maintenance." the 3085 surgical table preventive maintenance checklist states to perform the following twice annually, "5.1 secure all covers and shrouds.Apply rtv sealer to meet ipx4 requirements." the technician properly sealed the table and replaced the auxiliary controls, tested the table, confirmed it to be operating according to specifications, and returned it to service.The technician counseled facility personnel on the proper preventive maintenance activities, specifically properly sealing the table.No additional issues have been reported.

Event Description

The user facility reported that during a patient procedure their 3085 surgical table moved without being commanded to do so.No report of injury or procedure delay.The procedure was completed successfully.

• Brand Name: 3085 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: 8966766
• MDR Text Key: 209010244
• Report Number: 1043572-2019-00077
• 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: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• 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: 08/07/2019
• 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