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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 08/23/2019

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the 4085 surgical table and found the table to be operating according to specification.No repairs were required, and the table was returned to service.The technician was informed that during the time of the reported event an employee lowered the table inadvertently contacting an iv pole.The user facility did not realize the iv pole was creating an obstruction as the table was completely draped and continued to lower the surgical table onto the iv pole.This sequence caused the table to lift off of the floor.When the iv pole was removed, the table fell to the floor onto the employee's foot causing the reported injury.The root cause of the reported event can be attributed to user error as all equipment should be clear of the table before actuating a powered movement.The 4085 surgical table operator manual states (pg 1-3): "warning - personal injury and/or equipment damage hazard: failure to keep all personnel and equipment clear of the table before actuating any inertia- driven or power-driven movement could result in table damage and/or personal injury." a steris account manager is scheduled to conduct in-service training on (b)(6) 2019 on the proper use and operation of the 4085 surgical table.No additional issues have been reported.

Event Description

The user facility reported that an employee obtained an injury while lowering their 4085 surgical table during a patient procedure.Medical treatment was sought and administered.There was no report of injury to the patient.

• Brand Name: 4085 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: 9100437
• MDR Text Key: 208974485
• Report Number: 1043572-2019-00081
• 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: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2019
• Initial Date FDA Received: 09/20/2019
• 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