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

Device Problems Mechanical Problem (1384); Insufficient Information (3190)

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

Event Date 10/12/2021

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the table and was unable to duplicate the event.The 4085 surgical table operator manual states (4-7), "the steris 4085 general surgical table is equipped with an auxiliary control system.This system can be actuated at any time and allows table operation in the event of primary control malfunction.A pedal (foot pump to provide hydraulic power) and override hand control (see figure 4-4 and figure 4-6) are located on the right side of the table base behind a cover panel and are used for table movements." per the customer's request, the technician replaced the hand control cable and control board.Following the replacements, the technician tested the table, confirmed it to be operating according to specifications, and returned it to service.The hand control cable and control board have been returned to steris for evaluation; a follow-up mdr will be submitted when additional information becomes available.

Event Description

The user facility reported that during a patient procedure their 4085 surgical table was not responding to hand control commands to lower the table in height resulting in a procedure delay.User facility personnel elected to complete the procedure on the table without lowering it.No report of injury.

Manufacturer Narrative

During the technician's inspection, he was unable to duplicate the reported event.The table was tested and confirmed to be operating according to specification.The hand control cable assembly and master control board were replaced per the customer's request.The parts were returned to steris for evaluation and upon testing were found to be operating according to specifications.The reported event could not be duplicated.The table has been returned to service.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 ; 4403927453
• MDR Report Key: 12795657
• MDR Text Key: 282556599
• Report Number: 1043572-2021-00080
• 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: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2021
• 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: 10/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2016
• 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