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

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Pain (1994)

Event Date 06/07/2022

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite and found the pin to be sheared that goes through the seat lift cylinder.At the time of the reported event the 3085 surgical table was in reverse trend to allow a c-arm machine access around the table.Near the end of the procedure, when user facility commanded the surgical table to return to a level position, the front of the table dropped suddenly, causing the headrest to impact the floor and the patient to experience a jarring motion resulting in the reported injury.Based on the description of the event, it appears that the table's movement was obstructed by the c-arm or other piece of equipment in the room, preventing the desired movement.This resulted in extreme force on the table column subsequently causing the pin to shear off and the front section of the table to drop.Steris provided a quote to the user facility for repairs; the table has been removed from service until a decision on whether or not to repair the table is made by the user facility.The 3085 surgical table is not under a steris service contract and is serviced by a third-party service provider.The user facility disclosed service information that had been performed on the surgical table prior to the reported event.The table was last repaired in 2020 by the third-party servicer.Steris has not performed service on the 3085 surgical table since 2010.The 3085 surgical table was installed at the user facility in 2005 and has been in use for approximately 17 years.The 3085 surgical table's operator manual states (section 1), "during an articulation if the tabletop sections contact an obstruction, the table may tip.Before lowering either the table top or individual sections, remove possible obstructions.Do not allow leg section, when lowered, to contact the floor.When installing any table accessory, check for correct attachment and tighten securely (if appropriate).Do not use worn or damaged accessory.Check installation before using any accessory.Unanticipated table movement could cause patient injury.Patient must be secured to the table in accordance with recommended positioning practices.Possible patient or user injury, as well as table or accessory failure, may result from using steris table accessories for other than their stated purpose - or from using, on steris tables, accessories manufactured and sold by other companies.Patient injury may result if the operator of this table is not completely familiar with the controls for patient positioning and table operation." the 3085 surgical table's operator manual further states (section 4), "during an articulation if the tabletop sections contact an obstruction, the table may tip.Before lowering either the tabletop or individual sections, remove possible obstructions.Do not allow leg section, when lowered, to contact the floor." steris offered the user facility in-service training on the proper use and operation of the 3085 surgical table; the facility accepted this offer and is working with steris to schedule a date for this training.

Event Description

The user facility reported that during a patient procedure, user facility personnel commanded the 3085 surgical table to level.During this command, the table's front section dropped suddenly and impacted the floor.User facility personnel were able to reposition the patient and the procedure was completed successfully.A ct was performed and determined a subdural hematoma was present that was not there prior to the surgery.Patient was evaluated postoperatively by neurosurgery and no acute neurosurgical interventions indicated.

Manufacturer Narrative

Steris offered in-service training on the proper use and operation of the 3085 surgical table however, the user facility declined.No additional issues have been reported.

• 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: 15028643
• MDR Text Key: 304612125
• Report Number: 1043572-2022-00049
• 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,Followup
• Report Date: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 06/15/2022
• Initial Date FDA Received: 07/15/2022
• Supplement Dates Manufacturer Received: 06/15/2022
• Supplement Dates FDA Received: 09/24/2022
• 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