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

Device Problem Failure to Read Input Signal (1581)

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

Event Date 02/25/2021

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the 5085 surgical table and could not duplicate the reported event.The table was found to be operating properly; no repairs were required, and the table was returned to service.The technician spoke with user facility personnel who reported that the table was in trendelenburg fully slid to the head end at the time of the reported event.The reported event is attributed to user error as user facility personnel should have centered the tabletop prior to attempting to level the table as stated in the operator manual.The 5085 surgical table operator manual states (1-4), "warning - personal injury and/or equipment damage hazard (cont'd): with patient in normal or reverse orientation, table in trendelenburg and slide at head limit, center tabletop before attempting to raise table to level or move into reverse trendelenburg." the technician counseled user facility personnel on the proper operation of the 5085 surgical table, specifically ensuring the tabletop is centered before attempted to level the table.No additional issues have been reported.

Event Description

The user facility reported that during a patient procedure their 5085 surgical table would not respond to the level hand control command.The patient was transferred to a different table resulting in a procedure delay.The procedure was completed successfully.No report of injury.

• 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: 11576597
• MDR Text Key: 265145399
• Report Number: 1043572-2021-00017
• 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: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2021
• 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
• Date Manufacturer Received: 02/25/2021
• 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