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

Device Problem Device Handling Problem (3265)

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

Event Date 11/06/2023

Event Type  malfunction  

Event Description

The user facility reported that at the end of a patient procedure their 4085 surgical table "tipped" as facility personnel were moving a patient from the surgical table to a transport table.No report of injury or procedure delay.

Manufacturer Narrative

A steris service technician arrived onsite to inspect the surgical table and found no issues with the function or operation of the table.While onsite, the technician learned that at the time of the event the floor locks of the surgical table were unlocked during the patient transfer resulting in the reported event.The 4085 general surgical table operator manual states: "warning - personal injury hazard: the floor locks must be engaged at all times when a patient is on the table.Failure to engage the floor locks before placing a patient on the table or disengaging the floor locks while a patient is on the table could result in the table rolling unexpectedly during the procedure." a steris account manager conducted in-service training on december 1, 2023 on proper use and operation of the surgical table specifically ensuring floor locks are always engaged when a patient is present on the table.No additional issues have been reported.

• 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
• MDR Report Key: 18282134
• MDR Text Key: 329935072
• Report Number: 1043572-2023-00165
• 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: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• 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: 11/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2014
• 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