MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 5095 SURGICAL TABLE

Model Number 5095 SURIGICAL TABLE

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Discomfort (2330)

Event Date 05/04/2022

Event Type  malfunction  

Event Description

The user facility reported that during a patient procedure, an employee obtained an injury to their back while attempting to re-position one of their 5095 surgical tables that was sticking to the floor.No report of procedure delay.The user facility did not disclose if medical treatment was sought or administered.

Manufacturer Narrative

A steris service technician arrived onsite to inspect the table and found it to be operating properly.The technician observed the floor and floor locks and found that there was resistance when attempting to move the unlocked table.The technician noted debris on the floor locks and determined that the cause of the 5095 surgical table sticking to the floor is likely attributed to the solution utilized by facility personnel to clean the floor.The facility utilizes diversey virex plus one-step disinfectant cleaner & deodorizer to clean the floor.It is unknown if the user facility follows the directions for use as indicated on the label.The 5095 general surgical table operator manual states (6-6), "cleaning casters and floor locks (weekly) check table casters and floor locks for accumulated debris." the technician inspected the other 5095 surgical tables at the user facility and observed similar debris on the floor locks.The technician proactively replaced the floor locks, tested the tables, confirmed them to be operating according to specification, and returned them to service.A steris account manager will provide in-service training on the proper cleaning techniques for the 5095 surgical table.No additional issues have been reported.

Manufacturer Narrative

A steris account manager completed an in-service training on the proper cleaning techniques for the 5095 surgical table.No additional issues have been reported.

• Brand Name: 5095 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: 14573588
• MDR Text Key: 301012251
• Report Number: 1043572-2022-00041
• Device Sequence Number: 1
• Product Code: FQO
• UDI-Device Identifier: 00724995195649
• UDI-Public: 00724995195649
• 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: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5095 SURIGICAL TABLE
• Device Catalogue Number: ST015211002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2021
• 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