MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 5085 SURGICAL TABLE

Device Problem Unintended System Motion (1430)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2021

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the table and was unable to duplicate the reported event.During his inspection, the technician heard a clicking noise while sliding the table towards the head end.The table is not under steris service agreement for maintenance activities; the user facility is responsible for all maintenance activities.The technician replaced the table slide assembly, tested the table, confirmed it to be operating according to specification, and returned it to service.No issues have been reported.

Event Description

The user facility reported that during a patient procedure their 5085 surgical table was in reverse trendelenburg position and the table top began to slide in a downward direction without being commanded to do so.User facility personnel repositioned the table and completed the procedure successfully.No report of injury or procedure delay.

Manufacturer Narrative

The slide assembly was returned to steris for evaluation, and it was found that the internal gears were damaged.As the gears were damaged, this prevented the tabletop from remaining locked.An exact cause of the damage to the gears could not be determined.The user facility was provided a replacement slide assembly which was installed shortly after the reported event.No issues have been reported with the replacement slide assembly.

• Brand Name: 5085 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: 12525784
• MDR Text Key: 273130942
• Report Number: 1043572-2021-00068
• 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: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• 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: 08/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2018
• 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